Spinal Cord Stimulation in Patients with Diabetic Foot Disease: Prognosis Determined using Infrared Thermography as a Diagnostic Test

Spinal Cord Stimulation in Patients with Diabetic Foot Disease: Prognosis Determined using Infrared Thermography as a Diagnostic Test | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Spinal Cord Stimulation in Patients with Diabetic Foot Disease: Prognosis Determined using Infrared Thermography as a Diagnostic Test Min Bao, Mingjie Zhang, Hongyu Qu This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4935489/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective We aimed to determine whether perioperative infrared thermography (IRT) could be used as an index of success in the treatment of spinal cord stimulation (SCS) in patients with diabetic foot (DF) disease and in selecting suitable candidates for long-term SCS. METHODS Thirty-three patients with DF meeting our study inclusion criteria underwent permanent SCS implantation at the Shengjing Hospital of China Medical University from January 2021 to August 2023. Patients were grouped preoperatively based on the Wagner grading system for DF ulcers, and peripheral neuropathy was tested using a 10 g monofilament. The patients underwent temporary SCS following acompleting routine preoperative examination. IRT was performed preoperatively and at 1 week postoperatively, while lower limb skin temperature was recorded at multiple points and the mean value was calculated. During the temporary SCS test, patient pain was relieved satisfactorily; therefore, all patients subsequently underwent permanent SCS implantation and participated in a 6-month follow-up, with no complications leading to device removal. The patients were divided into two groups according to limb salvage status (treatment success group, no minor or major amputation during the follow-up postoperative period; treatment failure group, minor or major amputation performed during the follow-up period). To evaluate whether there were differences in patient baseline clinical data and the success rate of surgery according to different Wagner ulcer grades, a receiver operating characteristic curve was used to analyze the indicators of IRT. Logistic regression analysis was performed for large-fiber neuropathy, ulcer grade and the preoperative IRT. RESULTS All patients received permanent SCS and were followed up for 6 months. All patients had different degrees of pain relief (preoperative visual analog score [VAS], 6.82 ± 1.32; postoperative VAS, 5.48 ± 1.18; P < 0.001). Fifty-two limbs were salvaged during the follow-up period (SCS success rate, 78.8%). No significant difference in the SCS success rate in the affected limbs was observed between the different Wagner ulcer groups ( P = 0.293). In the treatment success group, the mean preoperative IRT temperature was 31.35 ± 1.92°C, the mean postoperative IRT temperature was 31.99 ± 1.86°C, and the mean lower limb skin temperature increased by 0.65°C. In the treatment failure group, the mean preoperative IRT temperature in the lower limbs was 32.38 ± 2.25°C, and the mean IRT temperature at 1 week postoperatively was 31.69 ± 1.78°C, showing a decrease of 0.70°C. The SCS success rate was 59.1% in limbs with large-fiber neuropathy, and 88.6% in limbs without large-fiber neuropathy, and the difference was statistically significant ( P = 0.007). We calculated the difference between perioperative IRT temperatures in the same limb and compared mean pre- and postoperative IRT temperatures. The diagnostic threshold for IRT alone was − 0.12°C, i.e., a -0.12°C increase postoperatively compared with preoperatively (positive predictive value, 91.84%; negative predictive value, 58.82%; AUC IRT , 0.79 [0.63–0.95], P < 0.001). Combined large-fiber neuropathy ( P = 0.025) and the difference in perioperative IRT mean values ( P = 0.001) were statistically significant for the diagnosis of SCS treatment results. CONCLUSION SCS treatment effectively relieved lower limb pain. Patients with DF and large fiber neuropathy had a lower surgical success rate, IRT was significantly higher in the treatment success group, and patients with peripheral neuropathy or a mean increase in perioperative lower limb IRT temperatures of < − 0.12°C were not suitable candidates for long-term SCS. IRT can be used as a diagnostic index for the prognosis of patients with DF receiving SCS and select suitable long-term SCS treatment candidates. diabetic foot infrared thermography lower limb ischemia neuropathy spinal cord stimulation Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 1. INTRODUCTION Spinal cord stimulation (SCS), as a neuromodulation treatment, has shown satisfactory results in the treatment of ischemic diseases in recent years. In patients with peripheral arterial occlusive disease (PAOD), this treatment has been reported to relieve pain and promote ulcer healing through improving lower limb arterial circulation and in limb salvage [ 1 , 2 ] . As an invasive neurosurgical intervention and considering the spinal cord neuronal circuit’s key role in regulating lower limb vessels in the lumbar enlargement, SCS is applied at the thoracic region of T11–T12 to spread an electrical current generated by a neurostimulator to the spinal cord through leads implanted in the epidural space of the spinal cord (one implanted patchy electrode) and block the pain sensation from uploading to the brain center to achieve pain relief. The aim of SCS treatment is from initially to treat intractable pain and improve motor function for certain patients with spinal cord lesions to now to improve lower limb blood flow, and its therapeutic effect has been previously investigated. Through improving blood flow to the lower limbs, SCS can improve patients’ walking ability, promote ulcer healing, and increase skin temperature. Peripheral arterial disease and peripheral neuropathy, as long-term complications of diabetes mellitus (DM), pose a threat to patients' lower limb health and lead to a decrease in patient quality of life. The prevalence of foot ulcers in patients diagnosed with DM ranges from 4–10%, while the annual incidence of diabetic foot (DF) disease has been reported to range from 1.0–4.1% in those with DM, and the lifetime incidence may be as high as 25%. DM-related foot ulcers are mostly due to neurological, vascular, and biomechanical factors, and approximately 50–60% of ulcers are infected. Approximately 20% of moderate to severe infections do not heal easily, resulting in severe gangrene; thus, leading to lower limb amputations and considerable economic costs to patients and their families [ 3 – 5 ] . Moreover, some patients require psychiatric treatment [ 6 ] . Treatment for DF has previously focused mainly on nerve regeneration through pharmacological treatment. Other treatments include lower extremity interventional therapies such as stent or interventional balloon therapy; lower extremity vascular bypass to increase blood flow to improve ischemic symptoms; and wound care, such as negative pressure drainage, debridement dressings, and anti-infective therapy. SCS is costly compared with standard treatments [ 7 ] ; therefore, it is important to select suitable candidates for long-term SCS. SCS treatment can be divided into two segments (Step 1, the test stage; Step 2, the long-term treatment stage) [ 8 ] . The high cost of SCS primarily involves Step 2 in terms of battery and postoperative maintenance. Step 1 provides an opportunity to evaluate a patient’s prognosis according to their performance during the testing phase to reduce the risk of treatment failure. Noninvasive assessment methods used to analyze the effects of peripheral arterial circulation in SCS include Doppler ultrasonography, scoring scales, and transcutaneous oxygen partial pressure, in addition to invasive techniques. The presence or absence of neuropathy has been reported to be associated with patient prognosis [ 9 ] . However, no reliable indicators are available to determine prognosis in SCS treatment. Compared with the above methods, infrared thermography (IRT) is a simple and effective examination method that can reflect peripheral microvascular flow. IRT captures the infrared radiation of the electromagnetic spectrum and processes an image to represent the temperature of the study object through a series of colors. It has been shown to be feasible for PAOD evaluation and has also been successfully applied in the diagnosis of breast cancer, and DM-related neuropathy [ 10 , 11 ] . In this retrospective study, we aimed to determine whether IRT findings pre- and post-temporary SCS implantation in patients with DF are associated with prognosis, and to identify patients suitable for long-term SCS treatment using changes in perioperative IRT mean values as a diagnostic method. 2. MATERIALS AND METHODS 2.1 Participants This study was approved by the Ethics Committee of our tertiary care hospital (batch number: 2021PS066J) and was conducted in accordance with the Declaration of Helsinki. The included study patients had been admitted to the Shengjing Hospital of China Medical University between January 2021 and August 2023 and had undergone SCS treatment. The Wagner grading system was used to grade foot ulcer severity. All patients provided written informed consent after receiving a full explanation of the procedure and associated risks and agreed to participate in the investigation and follow-up. 2.1.1 Inclusion criteria The inclusion criteria comprised patients who provided informed consent, who failed to respond to conventional treatment (including conservative medical treatment and foot surgical care), who had undergone an amputation caused by DF, who had rest pain affecting sleep and other aspects of life, whose lower limb arterial angiography findings were suggestive of distal arteriolar occlusion, and who were unsuitable candidates for bypass surgery or angioplasty. 2.1.2 Exclusion criteria The exclusion criteria comprised patients with severe cardiac and renal dysfunction, osteomyelitis, peripheral neuropathy owing to other causes (alcohol consumption), a life expectancy of < 6 months owing to other concomitant diseases, or patients deemed unable to adhere to the study protocol. 2.2 Method of assessment 2.2.1 The Wagner grading system The Wagner grading system is a method to classify DF lesions. It comprises a six-level linear description from pre-ulcer assessment (grade 0) to extensive foot gangrene (grade 5) [ 12 ] . Using Wagner grading, Grade 0 refers to a high-risk DF with no current ulceration but with high-risk factors for ulcer formation and infection, with severe ischemia, neuropathy, and paresthesia. Grade 1 refers to a high-risk foot with a superficial currently non-infected ulceration. Grade 2 refers to a high-risk DF with a deeper ulcer, often associated with soft tissue infection, but no abscess or bone involvement and no osteomyelitis. Grade 3 refers to a DF with a deep ulcer and deeper infection, often associated with abscess and osteomyelitis. Grade 4 refers to a DF with localized gangrene or gangrenous tissue that cannot recover. Grade 5 refers to a DF with most or total foot infection and > 50% foot gangrene. The DF ulcers were assessed by the same senior surgeon to reduce selection bias. We included 33 study patients and we performed separate evaluations on the patients’ lower limbs, with 39 classified as Wagner Grade 0, 17 classified as Wagner Grades 1–2, and 10 classified as Wagner Grades 3–5. 2.2.2 Assessment of peripheral neuropathy using a 10 g monofilament test The presence of peripheral neuropathy was assessed using a 10 g monofilament test, which is simple, reliable, and noninvasive [ 13 , 14 ] . Each patient was first informed of the purpose of the examination, after which pressure with a 10 g nylon thread was applied at the wrist to familiarize the patient to the pressure sensation created using the monofilament. The patients’ eyes were subsequently masked, and three sites were selected for each foot. The monofilament was applied vertically to the skin until the nylon wire bent for approximately 2–3 s. The patient was instructed to indicate when they felt a pressure sensation during the monofilament testing. Lesions such as ulcers, calluses, and dry gangrene were avoided during the testing. Patients were considered to have neuropathy if they did not respond to one test pressure point. Given the symmetry of DM-related peripheral neuropathy in the lower limbs and feet, no separate statistics were collected for the lower limb. 10 g monofilament tests are used to detect large-fiber bundle lesions; therefore, if a patient fails to detect 10 g of pressure applied to the skin, there is a loss of protective pain perception [ 13 ] . In our study, 11 patients tested positive, that is, all 22 limbs were regarded as having DM-related large-fiber bundle neuropathy. 2.2.3 Assessment method using a pain visual analogue scale (VAS) We used a vernier ruler approximately 10 cm in length with 10 scales on one side and "0" and "10" at each end. A score of 0 represented no pain and a score of 10 represented the most intolerable pain. Investigations were performed preoperatively and at 1 week postoperatively. 2.2.4 Application of IRT technology We measured lower limb skin temperature using a Korean Madison IRT system (T-1000smart; temperature sensitivity, 0.01 ºC). This instrument measures the temperature of the human epidermis using infrared imaging, which in turn reflects the peripheral microcirculation. We measured the symmetrical left and right five selected sites of the bilateral lower limbs: the pre-tibial, the dorsal surface of the foot, the plantar surface of the foot, and the plantar surface of two toes (because some patients received amputation, the choice between the two toes is not fixed). As the IRT results were compromised owing to inflammation and wounds, we excluded sites < 2 cm from the wound edge of the ulcer. The patients were tested before and 1 week after surgery to form a control experiment. Routine procedures were as follows. Prior to surgery, each patient was placed in a seated position in a room at a constant temperature and protected from light, avoiding close proximity or exposure of the body to any measured heat or cold source, and away from air convection. These precautions were taken to minimize variables affecting the temperature measurements. The skin was exposed below the mid-thigh region for 10 min. An IRT instrument was then placed 0.5 m in front of the patient to measure the pre-tibial and dorsalis pedis temperatures. The patients extended their knees in a recumbent position and extended their feet over the table, exposing the skin for 10 min, and subsequently, the temperature of the plantar surface of both toes was measured. The measurement sites were marked for accurate postoperative positioning. The procedure was repeated approximately one week after surgery at same examination time (for example, the examination was performed at 10 am, and the postoperative examination was still performed at 10 am). Data were obtained twice for comparison. As shown in Fig. 1 . The upper and lower parts in the picture are pre- and postoperative, respectively. 2.3 Surgical procedures The first stage of SCS surgery consisted of electrode implantation and temporary external stimulation with an operation time of approximately 45 min. The aim of this procedure was to perform SCS immediately postoperatively, determine the short-term index improvement, and as a preparation and evaluation technique prior to the two-stage surgery. The procedure details were as follows. The patient was placed in the prone position, C-arm positioning, and routine disinfection draping. A 5-cm straight incision was made in the central line of T11, the T11 lamina was incised, a Medtronic SPECIFY 2X 8 electrode (USA) was placed outside the dura mater, and fluoroscopic imaging was performed. The resistance was tested, electrode parameters were adjusted, and the incision was sutured. Secondary SCS, including permanent internal stimulator implantation, was performed after postoperative re-examination (within approximately 1 week). First, the exposed portions of the temporary stimulator extension were removed and routine disinfection draping was performed. After opening the original incision, the subcutaneous tissue was separated on the flank to form a pocket, and a subcutaneous tunnel was created between original incision and the pocket. The electrode was placed through a subcutaneous tunnel, attached to the battery, and sutured to the incision. 2.4 Clinical evaluation Based on a patient's clinical symptoms, signs, and auxiliary examinations, we analyzed pain relief and clinical improvement preoperatively and at 1 week postoperatively. The patients then presented to the clinic for approximately 3 months and were followed up for at least 6 months. Most patients stated that following SCS, rest pain was replaced with tolerable paresthesia, analgesic intake was reduced, and foot temperature increased, while foot ulcers or gangrene levels improved in some patients. As analgesic drugs are routinely used to suppress surgical incision pain within 3 days postoperatively, pain assessment is generally performed when analgesic drugs are discontinued after postoperative day 5. Some patients underwent enhanced computed tomography (CT) scans of the lower limb arteries. Treatment success was defined as no amputation or toe amputation within 6 months of postoperative follow-up, and treatment failure was defined as amputation or toe amputation within 6 months of surgery. 2.5 Data analysis Group t -tests and non-parametric tests were used to analyze the basic clinical data of the two groups. For different ulcer grades, differences in the success rates of surgery were tested using single sequential table analysis. Paired t -test was used to evaluate whether there was a difference in the mean values of preoperative and postoperative infrared thermography between the two groups and ROC curve was used to analyze perioperative infrared thermography to obtain the diagnostic threshold. A likelihood ratio chi-square test was used to analyze whether there were differences in treatment outcomes in patients with large-fiber neuropathy and without. Finally, logistic regression analysis was performed for three variables in combination, namely, large-fiber neuropathy, ulcer grade and IRT differences, to investigate the influencing factors of treatment outcomes. P -values < 0.05 were considered statistically significant. All statistical analyses were performed using SPSS 23.0, GraphPad Prism 10.0, and Medcalc 22.0 statistical software. 3. RESULTS 3.1 General statistical data In our study, patients’ bilateral lower limbs were counted separately (n = 66 lower limbs). All patients were treated with permanent SCS and followed up, and no patients were excluded from follow-up (see flow diagram in Fig. 2 ). The mean patient age was 66.67 ± 12.38 years (8 females, 25 males; mean DM duration, 17.23 ± 10.99 years). Of 39 limbs graded 0 using the Wagner grading system, 32 were either not amputated or were amputated during the postoperative follow-up period; the remaining seven limbs failed SCS treatment. Of 17 limbs with Wagner grades 1–2, 14 were successfully treated; three were amputated or amputated during follow-up. Of 10 limbs with Wagner grades 3–5, six were successfully treated, and no surgical treatment (except local tissue debridement surgery) was performed during the follow-up period. The remaining four limbs were considered treatment failures as they required amputation. Our SCS treatment success rate was 78.8%, and 21.2% of the limbs were amputated or amputated during follow-up. All patients experienced relief from leg pain during testing. The preoperative VAS score was 6.82 ± 1.32. The postoperative VAS score was 5.48 ± 1.18 (Table 1 ) . The statistical results of the contingency tables showed no significant differences in treatment success rates according toby the ulcer grade (Table 2 ). Table 1 Baseline demographic and clinical characteristics of the study population presented according to follow-up outcome groupings Success Failure P Age(years) 66.48(13.16) 67.36(9.27) 0.816 Gender(male) 19(73.1%) 6(85.7%) 0.765* Duration of diabetes 16.37(11.71) 20.43(7.25) 0.157* Pre-VAS score 6.75(1.32) 7.07(1.33) 0.424 Post-VAS score 5.48(1.24) 5.50(0.94) 0.957 Using group t -tests and non-parametric tests, no statistical difference in the baseline clinical data was observed between the two groups. *Indicates a non-parametric test result Table 2 Outcomes of total limb SCS surgery according to the Wagner classification grading Success (numbers of limbs) Failure (numbers of limbs) Total (numbers of limbs) Wagner grade 0 32 7 39 Wagner grade 1–2 14 3 17 Wagner grade 3–5 6 4 10 Total (numbers of limbs) 52 14 66 A Kruskal-Wallis test showed no difference in success rate among the different grades ( P = 0.293) A reduction in ulcer size and perioperative enhanced CT of the lower extremity arteries were not outcome measures in our study; however, the results obtained from two patients with well-established relevant records are worthy of note in this regard. The affected foot shown in Fig. 3 achieved limb salvage and a reduction in the foot ulcer area, with a pleasing clinical course of recovery. Imaging examinations of the lower extremities facilitated the observation of microcirculatory changes more clearly, as shown in Fig. 4 , using contrast-enhanced CT of the lower extremity arteries prior to surgery compared with 1 week postoperatively in both patients. The microcirculation in both lower limbs was found to have improved. Preoperatively, the skin on this patient’s feet had blackened, with localized digital dry gangrene observed. Postoperatively, the microcirculation recovered, skin color gradually returned to normal, and the extent of dry gangrene had reduced. Pre- and postoperative images of a female patient in the upper half of this figure, preoperative distal artery occlusion, and postoperative blood supply recovery. In the lower half of the picture, in a male patient, the microcirculation improved significantly postoperatively, and beaded changes in the peripheral vessels were all alleviated postoperatively. 3.2 IRT diagnosis In the successfully treated limbs, the mean IRT in the lower limbs increased from 31.35 ± 1.93 ℃ preoperatively to 31.99 ± 1.86 ℃ postoperatively. In patients who underwent major amputation or toe amputation during follow-up, the mean IRT was 32.38 ± 2.25°C preoperatively and decreased to 31.69 ± 1.78°C postoperatively. We calculated the difference value of perioperative IRT in the same limb, and the obtained result was recorded as the △IRT (mean postoperative IRT minus mean preoperative IRT). In the treatment success group, the △IRT was 0.65 ± 0.97°C; in the treatment failure group during follow-up, the △IRT was − 0.70 ± 1.23°C. The results of the △IRT were statistically significant between the treatment success and failure groups ( P < 0.001; Fig. 5 ). Based on ROC curve analysis, the diagnostic threshold for a diagnosis of IRT alone was calculated, that is, △IRT = -0.12°C (sensitivity, 88.54%; specificity, 71.43%; positive predictive value, 91.84%; negative predictive value, 58.82%; likelihood ratio [LR] + 3.03; LR − 0.19 [Medcalc 22.0]; AUC △IRT , 0.79[0.63–0.95], P < 0.001 [GraphPad Prism 10.0]). As shown in Fig. 6 . The △IRT was 0.65 ± 0.97 ℃ in the treatment success group and − 0.70 ± 1.23 ℃ in the treatment failure group ( P < 0.001). 3.3 Results of patients with large-fiber conduction bundle injury Following the 10 g monofilament test, the patients were divided into groups according to whether they had large-fiber neuropathy, and postoperative treatment efficacy was statistically analyzed. Of 11 patients with large-fiber conduction bundle injuries, 13 limbs were successfully treated, and the remaining nine limbs were amputated during follow-up. The overall procedural success rate was 59.1%. The remaining 22 patients had no combined large-fiber conduction bundle injuries, 39 limbs were successfully treated during follow-up, and five limbs could not be salvaged. Long-term SCS treatment was found to be more likely to be successful in patients without large-fiber bundle injury (Table 3 ), as calculated using the LR and a chi-square test ( P = 0.007). Table 3 Outcome of SCS procedure in all patients based on a 10 g monofilament test Success (numbers of limbs) Failure (numbers of limbs) Total (numbers of limbs) 10g-test (-) (numbers of limbs) 39 5 44 10g-test (+) (numbers of limbs) 13 9 22 Total (numbers of limbs) 52 14 66 A likelihood ratio chi-square test indicated a significant difference in the success rate of SCS surgery for patients with or without large fiber neuropathy ( χ = 7.288, P = 0.007). 3.4 Predictors of treaetment outcome Logistic regression analysis was performed for large-fiber neuropathy, ulcer grade and the △IRT, indicating significant differences in large-fiber neuropathy ( P = 0.025) and the △IRT ( P = 0.001, SPSS, 23.0). This suggested that large-fiber neuropathy and the △IRT are associated with long-term SCS treatment outcomes (Table 4 ). However, the two dumb variables in ulcer grade were not statistically significant, indicating that there was no statistical difference between Wagner system grade 0 and Wagner system grade 3–5; there was no statistical difference between Wagner system grade 1–2 and Wagner system grade 3–5. Table 4 Logistic Regression Results β 95% confidence interval P Wagner grade* -1.014 0.363(0.034, 3.886) 0.402 Wagner grade** -0.836 0.434(0.032, 5.811) 0.528 large-fiber neuropathy 2.128 8.394(1.313, 53.661) 0.025 △IRT 1.772 5.883(2.008, 17.231) 0.001 Wagner grade* and Wagner grade** represented the first dumb variable and the second dumb variable in ulcer grading variable, respectively. For Wagner Grade 3–5, both dumb variables are 0; for Wagner Grade 1–2, the first dumb variable is 0 and the second dumb variable is 1; for Wagner Grade 0, the first dumb variable is 1 and the second dumb variable is 0. Treatment success was considered a positive result. 4. DISCUSSION Infrared radiation is electromagnetic radiation emitted by the human body. Infrared thermal imaging technology generates two-dimensional heat maps through capturing infrared radiation, which is a representative method to visualize temperature distribution [ 15 ] . Humans are homeothermic animals, and the skin has a key role in regulating temperature, mainly through autonomic responses, including cutaneous vasomotor and sweating responses [ 16 ] . In the extremities of the human body, microcirculatory vessels and their environment have the most significant effects on skin temperature [ 11 ] . IRT has been widely used in clinical practice to reflect microcirculatory blood flow changes through detecting skin temperature and has been reported to predict the prognosis of ulcerated wounds in patients without DM [ 17 ] . In DM-related diseases, IRT is recommended as a screening tool to assess high-risk DF disease owing to its simplicity, effectiveness, safety, and non-invasiveness [ 18 ] . For patients with DF, common long-term complications include microangiopathy and autonomic neuropathy, resulting in the coexistence of ischemic and neuropathic pain, markedly reducing patient quality of life and increasing the risk of amputation [ 1 , 4 ] . Currently, the drugs used in clinical practice are mainly used to relieve pain [ 19 ] . Previous studies have shown that SCS relieves lower extremity pain; however, a recent randomized controlled trial showed that the long-term analgesic effect of SCS is influenced through the placebo effect and public opinion orientation [ 20 ] . It has been reported that patients' perception of pain improvement following SCS treatment decreases with longer implantation times; pain relief is evident at initial implantation due to abnormal sensations resulting from high neuronal charge transfer replacing nociceptive pain [ 21 ] . However, with prolonged treatment, this abnormal sensation may lead to the patient experiencing discomfort later in life, which could be an adaptive phenomenon in patients with chronic pain [ 22 , 23 ] . For patients with severe DF, the aim of SCS treatment is both pain relief and limb preservations [ 9 , 24 ] . SCS is considered as a second-line treatment modality for painful DM-related peripheral neuropathy [ 25 , 26 ] . SCS has been suggested to relieve ischemic pain through inhibiting pain signaling, leading to reduced sympathetic activity and improved skin microcirculation. One study suggested that spinal cord stimulation suppresses sympathetic autonomic activity and dilates peripheral microcirculatory vessels [ 27 , 28 ] , which was confirmed with skin temperature changes in the IRT responses. It has also been suggested that an improvement in blood flow to the lower extremities may be associated with a reduction in inflammatory responses and an improvement in vascular endothelial function [ 29 , 30 ] . In this study, pain symptoms improved in all patients, the postoperative pain scores of patients in both groups with different treatment results were significantly lower than those taken prior to surgery, and no difference in pain scores was observed at the same stage between the two groups, indicating short-term pain relief post-SCS treatment. Through analyzing the mean values of the △IRT between the treatment success and failure groups, we observed a difference in mean values of the △IRT between the two groups. Specifically, the treatment success group had higher mean postoperative IRT values than those prior to surgery, while the treatment failure group had lower mean postoperative IRT values than those prior to surgery. This difference in the mean values of the △IRT between the two groups may reflect differences in the hemodynamics of an affected limb post-SCS treatment: the mean postoperative IRT value was higher than that of the affected limb prior to surgery and the microcirculation improvement of the affected limb was better than that of the limb without significant change pre- and postoperatively. Further analysis yielded a cut-off value of -0.12 ℃ for the △IRT. This indicated that the affected limb with the △IRT >-0.12°C had a high likelihood of successful treatment and limb salvage. This study’s findings showed that the success of treatment was independent of foot ulcer grade. In addition, the prognosis of SCS in patients with DF and large-fiber neuropathy is generally poor, with a surgical success rate of 59.1%, which is lower than the overall surgical success rate of 78.8% found in our study. This may be because neuropathy affects vasomotor responses, leading to reduced benefits in relation to SCS treatment. In summary, given the success rate of surgery and the economic cost effect, we consider that patients with DF who have large-fiber neuropathy or the △IRT of <-0.12°C are not suitable candidates for long-term SCS treatment. However, this study had several limitations. The sample size was relatively small, with a single-center retrospective design with the likelihood of some bias. Only six-months treatment effects were observed in this study; the longer-term effects are unknown. Therefore, further studies are required to validate these results. Other objective evaluation indicators such as lower limb artery enhanced CT, lower limb artery ultrasound, and lower limb electromyography could be used to analyze the perioperative changes in the above indicators to obtain a specific risk scoring system or prognostic model. 5. CONCLUSION There are no reliable diagnostic indicators concerning SCS treatment outcomes. We analyzed the mean values of IRT, the severity of peripheral neuropathy, and the status of patients with DF who had undergone SCS treatment before and 1 week after surgery and at the follow-up endpoint. SCS safely and effectively improved the symptoms of lower limb ischemia and pain in patients with different degrees of DF disease and improves patient quality of life. IRT can be used as a diagnostic index for the prognosis of patients with DF receiving SCS and it has moderate diagnostic value. In clinical applications to screen patients suitable for long-term SCS treatment, we recommend that patients with DF who have large-fiber neuropathy or the △IRT <-0.12°C should be treated cautiously with permanent SCS. Declarations I, Hongyu Qu, declare that there are no conflicts of interest in relation to the manuscript titled "Spinal Cord Stimulation in Patients with Diabetic Foot Disease: Prognosis Determined using Infrared Thermography as a Diagnostic Test" submitted to Journal of Nondestructive Evaluation. I confirm that the results and interpretations reported in the manuscript are original and have not been plagiarized. I certify that I have read and understand the Journal of Nondestructive Evaluation conflict of interest policy, and I understand that failure to disclose a conflict of interest may result in the manuscript being rejected or retracted. I also certify that I have disclosed any financial or non-financial relationships that may be interpreted as constituting a conflict of interest in relation to this manuscript. I understand that this information will be subject to peer review, and I am willing to provide further information or clarification if required. I confirm that I have no known conflicts of interest that would influence the results or interpretation of the data presented in this manuscript, and I understand that failure to disclose a conflict of interest is unethical and may result in sanctions being imposed on me. Author Contribution M.B. and M.Z. designed the study. H.Q. collected and analyzed the data of patients, M.B. provided technical support. M.Z. and H.Q. wrote the manuscript. All authors reviewed the manuscript. Data Availability Data is provided within the manuscript or supplementary information files References De Vries, J., De Jongste, M.J., Spincemaille, G., Staal, M.J.: Spinal cord stimulation in ischemic heart and peripheral vascular disease. AdvTech Stand Neurosurg. ;32:63–89. (2007). 10.1007/978-3-211-47423-5_4 . PMID: 17907475 Ubbink, D.T., Vermeulen, H.: Spinal cord stimulation for nonreconstructable chronic critical leg ischemia. Cochrane Database Syst. Rev. 2013 (2), CD004001 (2013). 10.1002/14651858.CD004001.pub3 PMID: 23450547; PMCID: PMC7163280 Jeffcoate, W., Bakker, K.: World Diabetes Day: footing the bill. Lancet. Apr 30-May 6;365(9470):1527. (2005). 10.1016/S0140-6736(05)66437-9 . PMID: 15866295 Lazzarini, P.A., Hurn, S.E., Fernando, M.E., Jen, S.D., Kuys, S.S., Kamp, M.C., Reed, L.F.: Prevalence of foot disease and risk factors in the general inpatient population: A systematic review and meta-analysis. 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PMID: 34270842 Petrakis, I.E., Sciacca, V.: Spinal cord stimulation in diabetic lower limb critical ischemia: Transcutaneous oxygen measurement as a predictor for treatment success. Eur J Vasc Endovasc Surg. ;19(6):587 – 92. (2000). 10.1053/ejvs.1999.1036 . PMID: 10873725 Huang, C.L., Wu, Y.W., Hwang, C.L., Jong, Y.S., Chao, C.L., Chen, W.J., Wu, Y.T., Yang, W.S.: Application of infrared thermography in the evaluation of patients at high risk of lower-extremity peripheral arterial disease. J. Vasc Surg. 54 (4), 1074–1080 (2011). Epub 2011 Jul 23. PMID: 21784604 Lahiri, B.B., Bagavathiappan, S., Jayakumar, T., Philip, J.: Medical applications of infrared thermography: a review. Infrared Phys. Technol. 55 (4), 221–235 (2012). 10.1016/j.infrared.2012.03.007 Epub 2012 Apr 13. PMID: 32288544; PMCID: PMC7110787 Wagner, F.W. Jr.: Dysvascular foot: a system for diagnosis and treatment. Foot Ankle. ;2(2):64–122. (1981). 10.1177/107110078100200202 . PMID: 7319435 Tan, L.S.. Clinical use of the 10 g monofilament and its limitations: a review. Diabetes Res Clin Pract. ;90(1):1–7., Armstrong, D.G., Lipsky, B.A.: Prevention of foot ulcers in patients with diabetes. JAMA. 2005;293(2):217 – 28. doi: 10.1001/jama.293.2.217. PMID: 15644549 (2010) Pop-Busui, R., Boulton, A.J., Feldman, E.L., Bril, V., Freeman, R., Malik, R.A., Sosenko, J.M., Ziegler, D.: Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. ;40(1):136–154. (2017). 10.2337/dc16- 2042. PMID: 27999003; PMCID: PMC6977405 Adam, M., Ng, E.Y.K., Tan, J.H., Heng, M.L., Tong, J.W.K., Acharya, U.R.: Computer-aided diagnosis of diabetic foot using infrared thermography: a review. Comput. Biol. Med. 91 , 326–336 (2017). 10.1016/j.compbiomed.2017.10.030 Epub 2017 Oct 26. PMID: 29121540 Gilman, S.: Neurobiology of disease. Academic (2011) Torreblanca González, J., Gómez-Martín, B., Hernández Encinas, A., Martín-Vaquero, J., Queiruga-Dios, A., Martínez-Nova, A.: Infrared thermography has been used to develop and assess wearable shocks and monitor foot temperatures in subjects with diabetes. Sens. (Base). 21 (5), 1821 (2021). 10.3390/s21051821 PMID: 33807804; PMCID: PMC7961733 Bagavathiappan, S., Philip, J., Jayakumar, T., Raj, B., Rao, P.N., Varalakshmi, M., Mohan, V.: Correlation between plantar foot temperature and diabetic neuropathy: a case study by using an infrared thermal imaging technique. J. Diabetes Sci. Technol. 4 (6), 1386–1392 (2010). 10.1177/193229681000400613 PMID: 21129334; PMCID: PMC3005049 Cameron, N.E., Cotter, M.A.: Potential therapeutic approaches for the treatment or prevention of diabetic neuropathy: Evidence from experimental studies. Diabet Med. (1993). Aug-Sep;10(7):593–605 10.1111/j.1464-5491.1993.tb00131.x . PMID: 8403819 Hara, S., Andresen, H., Solheim, O., Carlsen, S.M., Sundstrøm, T., Lønne, G., Lønne, V.V., Taraldsen, K., Tronvik, E.A., Øie, L.R., Gulati, A.M., Sagberg, L.M., Jakola, A.S., Solberg, T.K., Nygaard, Ø.P., Salvesen, Ø.O., Gulati, S.: Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial. JAMA. 328 (15), 1506–1514 (2022). 10.1001/jama.2022.18231 PMID: 36255427; PMCID: PMC9579901 Rainville, P.: Brain mechanisms of pain affect and pain modulation. Curr Opin Neurobiol. ;12(2):195–204. (2002). 10.1016/s0959-4388(02)00313-6 . PMID: 12015237 Tesfaye, S., Watt, J., Benbow, S.J., Pang, K.A., Miles, J., MacFarlane, I.A.: Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. Lancet. Dec 21–28;348(9043):1698 – 701. (1996). 10.1016/S0140-6736(96)02467-1 . PMID: 8973433 Brümmer, U., Condini, V., Cappelli, P., Di Liberato, L., Scesi, M., Bonomini, M., Costantini, A.: Spinal cord stimulation in hemodialysis patients with critical lower-limb ischemia. Am J Kidney Dis. ;47(5):842-7. (2006). 10.1053/j.ajkd.2006.02.172 . PMID: 16632023 Kretzschmar, M., Okaro, U., Schwarz, M., Reining, M., Lesser, T.: Spinal Neuromodulation for Peripheral Arterial Disease of Lower Extremities: A Ten-Year Retrospective Analysis. Neuromodulation.2023Nov 21:S1094-7159(23)00937-6. 10.1016/j.neurom.2023.10.186 . Epub ahead of print. PMID: 38165292 Krog, L., Maloney, J., Pew, S., Adeleye, O., Johnson, B., Glenn, B., Gill, B., Tieppo Francio, V., Pagan-Rosado, R., Whitney, M., Sinha, N., Strand, N.: Cervical Spinal Cord Stimulation: A Review. Curr Pain Headache Rep. Dec 26. (2023). 10.1007/s11916-023-01200-8 . Epub ahead of print. PMID: 38147282 Slangen, R., Schaper, N.C., Faber, C.G., et al.: Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial. Diabetes Care. 37 (11), 3016–3024 (2014) Augustinsson, L.E., Carlsson, C.A., Fall, M.: Autonomic effects of electrostimulation. Appl Neurophysiol. ;45(1–2):185-9. (1982). 10.1159/000101596 . PMID: 6977320 Jensen, M.P., Brownstone, R.M.: Mechanisms of spinal cord stimulation for the treatment of pain: Still in the dark after 50 years. Eur. J. Pain. 23 (4), 652–659 (2019). 10.1002/ejp.1336 Epub 2018 Dec 3. PMID: 30407696; PMCID: PMC6491991 Linderoth, B., Foreman, R.D.: Physiology of spinal cord stimulation: review and update. Neuromodulation. ;2(3):150 – 64. (1999). 10.1046/j.1525-1403.1999.00150.x . PMID: 22151202 Taylor, R.S., Ryan, J., O'Donnell, R., Eldabe, S., Kumar, K., North, R.B.: The cost-effectiveness of spinal cord stimulation in the treatment of failed back surgery syndrome. Clin J Pain. (2010). Jul-Aug;26(6):463-9 10.1097/AJP.0b013e3181daccec . PMID: 20551721 Additional Declarations No competing interests reported. Supplementary Files file.xlsx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4935489","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":354616169,"identity":"bc4f0f62-25d0-4bb5-a580-436f7d84cbfe","order_by":0,"name":"Min Bao","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA0klEQVRIiWNgGAWjYFCCM1BagoHxQUKFDWlamA0enEkjRgsPXAub5MO2Q4Q1yDeePfbgY9s9OQbp7rSKBLYDDPzt3Ql4tRgcOJduOLOt2JhB5uy2Gwk8dxgkzpzdgF8Lwxkzad62hMQGiVygFolnDAYSufi1yDcAtfyFailIMDhMWAvDAaAWRqgWhoQEIrQYALVI9pxLAPlls0TCgTQegn6Rn3HGTOJHWQIwxHo3fvz5z0aOv72XgMMkDkBoeyjNg0shAvA3EFYzCkbBKBgFIxwAAGhtSzlxsRnKAAAAAElFTkSuQmCC","orcid":"","institution":"Shengjing Hospital of China Medical University","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Min","middleName":"","lastName":"Bao","suffix":""},{"id":354616170,"identity":"50303db7-7bfc-44fb-96db-cdc5d35a168b","order_by":1,"name":"Mingjie Zhang","email":"","orcid":"","institution":"Shengjing Hospital of China Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Mingjie","middleName":"","lastName":"Zhang","suffix":""},{"id":354616171,"identity":"d1bd8709-9c55-4285-b0b4-0bbca24c04db","order_by":2,"name":"Hongyu Qu","email":"","orcid":"","institution":"Shengjing Hospital of China Medical University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Hongyu","middleName":"","lastName":"Qu","suffix":""}],"badges":[],"createdAt":"2024-08-19 03:08:52","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4935489/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4935489/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":66574168,"identity":"b517d9b4-6bc9-481d-a096-c3d427191603","added_by":"auto","created_at":"2024-10-14 12:12:18","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":936702,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eExamination points\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-4935489/v1/e4dd42513c6035d4399515bb.png"},{"id":66574172,"identity":"dd73e549-3edd-49cf-ae11-04075d5f39b6","added_by":"auto","created_at":"2024-10-14 12:12:19","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":410138,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlow chart and follow-up results\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4935489/v1/812a49269f1dff0aba256597.jpeg"},{"id":66574548,"identity":"b87be54f-c55b-49c7-a6ec-cd12eea012a7","added_by":"auto","created_at":"2024-10-14 12:20:18","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":1124649,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eA pre-and postoperative comparison\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-4935489/v1/661bf79251d59de34d525b5b.png"},{"id":66574551,"identity":"407c2f3f-d348-48f0-bcf4-9d5306dd471f","added_by":"auto","created_at":"2024-10-14 12:20:19","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":484500,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThe comparison of contrast-enhanced CT\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-4935489/v1/1bf5587095c071f0f4318d1b.png"},{"id":66574176,"identity":"ddeedca9-1fc4-44be-a8ad-f50519bb1869","added_by":"auto","created_at":"2024-10-14 12:12:19","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":9671,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eComparison of △IRT between two groups\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage5.png","url":"https://assets-eu.researchsquare.com/files/rs-4935489/v1/26cf5e29a500ff87d9a79c82.png"},{"id":66574178,"identity":"99071622-ff82-42d1-ab15-2c885da0b9a8","added_by":"auto","created_at":"2024-10-14 12:12:19","extension":"jpeg","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":146363,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eThe AUC for △IRT; AUC\u003c/strong\u003e\u003csub\u003e\u003cstrong\u003e△IRT\u003c/strong\u003e\u003c/sub\u003e\u003cstrong\u003e, 0.79[0.63–0.95]\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage6.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4935489/v1/f877613833b95d975a52224f.jpeg"},{"id":81351117,"identity":"863b6f45-62d9-4cab-beb0-33953ab3e44b","added_by":"auto","created_at":"2025-04-25 06:24:02","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":4912430,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4935489/v1/6539ebe5-fbb2-4a73-8a13-cac08abc9566.pdf"},{"id":66574166,"identity":"91143f4c-fa49-47be-9b6a-d253a679fea9","added_by":"auto","created_at":"2024-10-14 12:12:18","extension":"xlsx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":22548,"visible":true,"origin":"","legend":"","description":"","filename":"file.xlsx","url":"https://assets-eu.researchsquare.com/files/rs-4935489/v1/724b747176bd3b001b4b7b30.xlsx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Spinal Cord Stimulation in Patients with Diabetic Foot Disease: Prognosis Determined using Infrared Thermography as a Diagnostic Test","fulltext":[{"header":"1. INTRODUCTION","content":"\u003cp\u003eSpinal cord stimulation (SCS), as a neuromodulation treatment, has shown satisfactory results in the treatment of ischemic diseases in recent years. In patients with peripheral arterial occlusive disease (PAOD), this treatment has been reported to relieve pain and promote ulcer healing through improving lower limb arterial circulation and in limb salvage\u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e. As an invasive neurosurgical intervention and considering the spinal cord neuronal circuit\u0026rsquo;s key role in regulating lower limb vessels in the lumbar enlargement, SCS is applied at the thoracic region of T11\u0026ndash;T12 to spread an electrical current generated by a neurostimulator to the spinal cord through leads implanted in the epidural space of the spinal cord (one implanted patchy electrode) and block the pain sensation from uploading to the brain center to achieve pain relief. The aim of SCS treatment is from initially to treat intractable pain and improve motor function for certain patients with spinal cord lesions to now to improve lower limb blood flow, and its therapeutic effect has been previously investigated. Through improving blood flow to the lower limbs, SCS can improve patients\u0026rsquo; walking ability, promote ulcer healing, and increase skin temperature. Peripheral arterial disease and peripheral neuropathy, as long-term complications of diabetes mellitus (DM), pose a threat to patients' lower limb health and lead to a decrease in patient quality of life. The prevalence of foot ulcers in patients diagnosed with DM ranges from 4\u0026ndash;10%, while the annual incidence of diabetic foot (DF) disease has been reported to range from 1.0\u0026ndash;4.1% in those with DM, and the lifetime incidence may be as high as 25%. DM-related foot ulcers are mostly due to neurological, vascular, and biomechanical factors, and approximately 50\u0026ndash;60% of ulcers are infected. Approximately 20% of moderate to severe infections do not heal easily, resulting in severe gangrene; thus, leading to lower limb amputations and considerable economic costs to patients and their families\u003csup\u003e[\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e. Moreover, some patients require psychiatric treatment\u003csup\u003e[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e. Treatment for DF has previously focused mainly on nerve regeneration through pharmacological treatment. Other treatments include lower extremity interventional therapies such as stent or interventional balloon therapy; lower extremity vascular bypass to increase blood flow to improve ischemic symptoms; and wound care, such as negative pressure drainage, debridement dressings, and anti-infective therapy. SCS is costly compared with standard treatments\u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e; therefore, it is important to select suitable candidates for long-term SCS. SCS treatment can be divided into two segments (Step 1, the test stage; Step 2, the long-term treatment stage)\u003csup\u003e[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e. The high cost of SCS primarily involves Step 2 in terms of battery and postoperative maintenance. Step 1 provides an opportunity to evaluate a patient\u0026rsquo;s prognosis according to their performance during the testing phase to reduce the risk of treatment failure. Noninvasive assessment methods used to analyze the effects of peripheral arterial circulation in SCS include Doppler ultrasonography, scoring scales, and transcutaneous oxygen partial pressure, in addition to invasive techniques. The presence or absence of neuropathy has been reported to be associated with patient prognosis\u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e. However, no reliable indicators are available to determine prognosis in SCS treatment. Compared with the above methods, infrared thermography (IRT) is a simple and effective examination method that can reflect peripheral microvascular flow. IRT captures the infrared radiation of the electromagnetic spectrum and processes an image to represent the temperature of the study object through a series of colors. It has been shown to be feasible for PAOD evaluation and has also been successfully applied in the diagnosis of breast cancer, and DM-related neuropathy\u003csup\u003e[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e. In this retrospective study, we aimed to determine whether IRT findings pre- and post-temporary SCS implantation in patients with DF are associated with prognosis, and to identify patients suitable for long-term SCS treatment using changes in perioperative IRT mean values as a diagnostic method.\u003c/p\u003e"},{"header":"2. MATERIALS AND METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1 Participants\u003c/h2\u003e \u003cp\u003e This study was approved by the Ethics Committee of our tertiary care hospital (batch number: 2021PS066J) and was conducted in accordance with the Declaration of Helsinki. The included study patients had been admitted to the Shengjing Hospital of China Medical University between January 2021 and August 2023 and had undergone SCS treatment. The Wagner grading system was used to grade foot ulcer severity. All patients provided written informed consent after receiving a full explanation of the procedure and associated risks and agreed to participate in the investigation and follow-up.\u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section3\"\u003e \u003ch2\u003e2.1.1 Inclusion criteria\u003c/h2\u003e \u003cp\u003eThe inclusion criteria comprised patients who provided informed consent, who failed to respond to conventional treatment (including conservative medical treatment and foot surgical care), who had undergone an amputation caused by DF, who had rest pain affecting sleep and other aspects of life, whose lower limb arterial angiography findings were suggestive of distal arteriolar occlusion, and who were unsuitable candidates for bypass surgery or angioplasty.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section3\"\u003e \u003ch2\u003e2.1.2 Exclusion criteria\u003c/h2\u003e \u003cp\u003eThe exclusion criteria comprised patients with severe cardiac and renal dysfunction, osteomyelitis, peripheral neuropathy owing to other causes (alcohol consumption), a life expectancy of \u0026lt;\u0026thinsp;6 months owing to other concomitant diseases, or patients deemed unable to adhere to the study protocol.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003e2.2 Method of assessment\u003c/h2\u003e \u003cdiv id=\"Sec7\" class=\"Section3\"\u003e \u003ch2\u003e2.2.1 The Wagner grading system\u003c/h2\u003e \u003cp\u003eThe Wagner grading system is a method to classify DF lesions. It comprises a six-level linear description from pre-ulcer assessment (grade 0) to extensive foot gangrene (grade 5)\u003csup\u003e[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e. Using Wagner grading, Grade 0 refers to a high-risk DF with no current ulceration but with high-risk factors for ulcer formation and infection, with severe ischemia, neuropathy, and paresthesia. Grade 1 refers to a high-risk foot with a superficial currently non-infected ulceration. Grade 2 refers to a high-risk DF with a deeper ulcer, often associated with soft tissue infection, but no abscess or bone involvement and no osteomyelitis. Grade 3 refers to a DF with a deep ulcer and deeper infection, often associated with abscess and osteomyelitis. Grade 4 refers to a DF with localized gangrene or gangrenous tissue that cannot recover. Grade 5 refers to a DF with most or total foot infection and \u0026gt;\u0026thinsp;50% foot gangrene. The DF ulcers were assessed by the same senior surgeon to reduce selection bias. We included 33 study patients and we performed separate evaluations on the patients\u0026rsquo; lower limbs, with 39 classified as Wagner Grade 0, 17 classified as Wagner Grades 1\u0026ndash;2, and 10 classified as Wagner Grades 3\u0026ndash;5.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section3\"\u003e \u003ch2\u003e2.2.2 Assessment of peripheral neuropathy using a 10 g monofilament test\u003c/h2\u003e \u003cp\u003eThe presence of peripheral neuropathy was assessed using a 10 g monofilament test, which is simple, reliable, and noninvasive\u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]\u003c/sup\u003e. Each patient was first informed of the purpose of the examination, after which pressure with a 10 g nylon thread was applied at the wrist to familiarize the patient to the pressure sensation created using the monofilament. The patients\u0026rsquo; eyes were subsequently masked, and three sites were selected for each foot. The monofilament was applied vertically to the skin until the nylon wire bent for approximately 2\u0026ndash;3 s. The patient was instructed to indicate when they felt a pressure sensation during the monofilament testing. Lesions such as ulcers, calluses, and dry gangrene were avoided during the testing. Patients were considered to have neuropathy if they did not respond to one test pressure point. Given the symmetry of DM-related peripheral neuropathy in the lower limbs and feet, no separate statistics were collected for the lower limb. 10 g monofilament tests are used to detect large-fiber bundle lesions; therefore, if a patient fails to detect 10 g of pressure applied to the skin, there is a loss of protective pain perception\u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e. In our study, 11 patients tested positive, that is, all 22 limbs were regarded as having DM-related large-fiber bundle neuropathy.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e \u003ch2\u003e2.2.3 Assessment method using a pain visual analogue scale (VAS)\u003c/h2\u003e \u003cp\u003eWe used a vernier ruler approximately 10 cm in length with 10 scales on one side and \"0\" and \"10\" at each end. A score of 0 represented no pain and a score of 10 represented the most intolerable pain. Investigations were performed preoperatively and at 1 week postoperatively.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003e2.2.4 Application of IRT technology\u003c/h2\u003e \u003cp\u003eWe measured lower limb skin temperature using a Korean Madison IRT system (T-1000smart; temperature sensitivity, 0.01 \u0026ordm;C). This instrument measures the temperature of the human epidermis using infrared imaging, which in turn reflects the peripheral microcirculation. We measured the symmetrical left and right five selected sites of the bilateral lower limbs: the pre-tibial, the dorsal surface of the foot, the plantar surface of the foot, and the plantar surface of two toes (because some patients received amputation, the choice between the two toes is not fixed). As the IRT results were compromised owing to inflammation and wounds, we excluded sites\u0026thinsp;\u0026lt;\u0026thinsp;2 cm from the wound edge of the ulcer. The patients were tested before and 1 week after surgery to form a control experiment. Routine procedures were as follows. Prior to surgery, each patient was placed in a seated position in a room at a constant temperature and protected from light, avoiding close proximity or exposure of the body to any measured heat or cold source, and away from air convection. These precautions were taken to minimize variables affecting the temperature measurements. The skin was exposed below the mid-thigh region for 10 min. An IRT instrument was then placed 0.5 m in front of the patient to measure the pre-tibial and dorsalis pedis temperatures. The patients extended their knees in a recumbent position and extended their feet over the table, exposing the skin for 10 min, and subsequently, the temperature of the plantar surface of both toes was measured. The measurement sites were marked for accurate postoperative positioning. The procedure was repeated approximately one week after surgery at same examination time (for example, the examination was performed at 10 am, and the postoperative examination was still performed at 10 am). Data were obtained twice for comparison. As shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The upper and lower parts in the picture are pre- and postoperative, respectively.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003e2.3 Surgical procedures\u003c/h2\u003e \u003cp\u003eThe first stage of SCS surgery consisted of electrode implantation and temporary external stimulation with an operation time of approximately 45 min. The aim of this procedure was to perform SCS immediately postoperatively, determine the short-term index improvement, and as a preparation and evaluation technique prior to the two-stage surgery. The procedure details were as follows. The patient was placed in the prone position, C-arm positioning, and routine disinfection draping. A 5-cm straight incision was made in the central line of T11, the T11 lamina was incised, a Medtronic SPECIFY 2X 8 electrode (USA) was placed outside the dura mater, and fluoroscopic imaging was performed. The resistance was tested, electrode parameters were adjusted, and the incision was sutured. Secondary SCS, including permanent internal stimulator implantation, was performed after postoperative re-examination (within approximately 1 week). First, the exposed portions of the temporary stimulator extension were removed and routine disinfection draping was performed. After opening the original incision, the subcutaneous tissue was separated on the flank to form a pocket, and a subcutaneous tunnel was created between original incision and the pocket. The electrode was placed through a subcutaneous tunnel, attached to the battery, and sutured to the incision.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003e2.4 Clinical evaluation\u003c/h2\u003e \u003cp\u003eBased on a patient's clinical symptoms, signs, and auxiliary examinations, we analyzed pain relief and clinical improvement preoperatively and at 1 week postoperatively. The patients then presented to the clinic for approximately 3 months and were followed up for at least 6 months. Most patients stated that following SCS, rest pain was replaced with tolerable paresthesia, analgesic intake was reduced, and foot temperature increased, while foot ulcers or gangrene levels improved in some patients. As analgesic drugs are routinely used to suppress surgical incision pain within 3 days postoperatively, pain assessment is generally performed when analgesic drugs are discontinued after postoperative day 5. Some patients underwent enhanced computed tomography (CT) scans of the lower limb arteries. Treatment success was defined as no amputation or toe amputation within 6 months of postoperative follow-up, and treatment failure was defined as amputation or toe amputation within 6 months of surgery.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003e2.5 Data analysis\u003c/h2\u003e \u003cp\u003eGroup \u003cem\u003et\u003c/em\u003e-tests and non-parametric tests were used to analyze the basic clinical data of the two groups. For different ulcer grades, differences in the success rates of surgery were tested using single sequential table analysis. Paired \u003cem\u003et\u003c/em\u003e-test was used to evaluate whether there was a difference in the mean values of preoperative and postoperative infrared thermography between the two groups and ROC curve was used to analyze perioperative infrared thermography to obtain the diagnostic threshold. A likelihood ratio chi-square test was used to analyze whether there were differences in treatment outcomes in patients with large-fiber neuropathy and without. Finally, logistic regression analysis was performed for three variables in combination, namely, large-fiber neuropathy, ulcer grade and IRT differences, to investigate the influencing factors of treatment outcomes. \u003cem\u003eP\u003c/em\u003e-values\u0026thinsp;\u0026lt;\u0026thinsp;0.05 were considered statistically significant. All statistical analyses were performed using SPSS 23.0, GraphPad Prism 10.0, and Medcalc 22.0 statistical software.\u003c/p\u003e \u003c/div\u003e"},{"header":"3. RESULTS","content":"\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003e3.1 General statistical data\u003c/h2\u003e \u003cp\u003eIn our study, patients\u0026rsquo; bilateral lower limbs were counted separately (n\u0026thinsp;=\u0026thinsp;66 lower limbs). All patients were treated with permanent SCS and followed up, and no patients were excluded from follow-up (see flow diagram in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The mean patient age was 66.67\u0026thinsp;\u0026plusmn;\u0026thinsp;12.38 years (8 females, 25 males; mean DM duration, 17.23\u0026thinsp;\u0026plusmn;\u0026thinsp;10.99 years). Of 39 limbs graded 0 using the Wagner grading system, 32 were either not amputated or were amputated during the postoperative follow-up period; the remaining seven limbs failed SCS treatment. Of 17 limbs with Wagner grades 1\u0026ndash;2, 14 were successfully treated; three were amputated or amputated during follow-up. Of 10 limbs with Wagner grades 3\u0026ndash;5, six were successfully treated, and no surgical treatment (except local tissue debridement surgery) was performed during the follow-up period. The remaining four limbs were considered treatment failures as they required amputation. Our SCS treatment success rate was 78.8%, and 21.2% of the limbs were amputated or amputated during follow-up. All patients experienced relief from leg pain during testing. The preoperative VAS score was 6.82\u0026thinsp;\u0026plusmn;\u0026thinsp;1.32. The postoperative VAS score was 5.48\u0026thinsp;\u0026plusmn;\u0026thinsp;1.18 (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003cb\u003e)\u003c/b\u003e. The statistical results of the contingency tables showed no significant differences in treatment success rates according toby the ulcer grade (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline demographic and clinical characteristics of the study population presented according to follow-up outcome groupings\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSuccess\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFailure\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge(years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e66.48(13.16)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e67.36(9.27)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.816\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGender(male)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e19(73.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e6(85.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.765*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDuration of diabetes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e16.37(11.71)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e20.43(7.25)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.157*\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePre-VAS score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6.75(1.32)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7.07(1.33)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.424\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePost-VAS score\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.48(1.24)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5.50(0.94)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.957\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eUsing group \u003cem\u003et\u003c/em\u003e-tests and non-parametric tests, no statistical difference in the baseline clinical data was observed between the two groups.\u003c/p\u003e \u003cp\u003e*Indicates a non-parametric test result\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u003cb\u003eOutcomes of total limb SCS surgery according to the Wagner classification grading\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSuccess\u003c/p\u003e \u003cp\u003e(numbers of limbs)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFailure\u003c/p\u003e \u003cp\u003e(numbers of limbs)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003cp\u003e(numbers of limbs)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWagner grade 0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e39\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWagner grade 1\u0026ndash;2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWagner grade 3\u0026ndash;5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003cp\u003e(numbers of limbs)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e66\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eA Kruskal-Wallis test showed no difference in success rate among the different grades (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.293)\u003c/p\u003e \u003cp\u003eA reduction in ulcer size and perioperative enhanced CT of the lower extremity arteries were not outcome measures in our study; however, the results obtained from two patients with well-established relevant records are worthy of note in this regard. The affected foot shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e achieved limb salvage and a reduction in the foot ulcer area, with a pleasing clinical course of recovery. Imaging examinations of the lower extremities facilitated the observation of microcirculatory changes more clearly, as shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e, using contrast-enhanced CT of the lower extremity arteries prior to surgery compared with 1 week postoperatively in both patients. The microcirculation in both lower limbs was found to have improved.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003ePreoperatively, the skin on this patient\u0026rsquo;s feet had blackened, with localized digital dry gangrene observed. Postoperatively, the microcirculation recovered, skin color gradually returned to normal, and the extent of dry gangrene had reduced.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003ePre- and postoperative images of a female patient in the upper half of this figure, preoperative distal artery occlusion, and postoperative blood supply recovery.\u003c/p\u003e \u003cp\u003eIn the lower half of the picture, in a male patient, the microcirculation improved significantly postoperatively, and beaded changes in the peripheral vessels were all alleviated postoperatively.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003e3.2 IRT diagnosis\u003c/h2\u003e \u003cp\u003eIn the successfully treated limbs, the mean IRT in the lower limbs increased from 31.35\u0026thinsp;\u0026plusmn;\u0026thinsp;1.93 ℃ preoperatively to 31.99\u0026thinsp;\u0026plusmn;\u0026thinsp;1.86 ℃ postoperatively. In patients who underwent major amputation or toe amputation during follow-up, the mean IRT was 32.38\u0026thinsp;\u0026plusmn;\u0026thinsp;2.25\u0026deg;C preoperatively and decreased to 31.69\u0026thinsp;\u0026plusmn;\u0026thinsp;1.78\u0026deg;C postoperatively. We calculated the difference value of perioperative IRT in the same limb, and the obtained result was recorded as the △IRT (mean postoperative IRT minus mean preoperative IRT). In the treatment success group, the △IRT was 0.65\u0026thinsp;\u0026plusmn;\u0026thinsp;0.97\u0026deg;C; in the treatment failure group during follow-up, the △IRT was \u0026minus;\u0026thinsp;0.70\u0026thinsp;\u0026plusmn;\u0026thinsp;1.23\u0026deg;C. The results of the △IRT were statistically significant between the treatment success and failure groups (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001; Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e). Based on ROC curve analysis, the diagnostic threshold for a diagnosis of IRT alone was calculated, that is, △IRT = -0.12\u0026deg;C (sensitivity, 88.54%; specificity, 71.43%; positive predictive value, 91.84%; negative predictive value, 58.82%; likelihood ratio [LR]\u003csub\u003e+\u003c/sub\u003e 3.03; LR\u003csub\u003e\u0026minus;\u003c/sub\u003e 0.19 [Medcalc 22.0]; AUC\u003csub\u003e△IRT\u003c/sub\u003e, 0.79[0.63\u0026ndash;0.95], \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001 [GraphPad Prism 10.0]). As shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e6\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe △IRT was 0.65\u0026thinsp;\u0026plusmn;\u0026thinsp;0.97 ℃ in the treatment success group and \u0026minus;\u0026thinsp;0.70\u0026thinsp;\u0026plusmn;\u0026thinsp;1.23 ℃ in the treatment failure group (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003e3.3 Results of patients with large-fiber conduction bundle injury\u003c/b\u003e\u003c/h2\u003e \u003cp\u003eFollowing the 10 g monofilament test, the patients were divided into groups according to whether they had large-fiber neuropathy, and postoperative treatment efficacy was statistically analyzed. Of 11 patients with large-fiber conduction bundle injuries, 13 limbs were successfully treated, and the remaining nine limbs were amputated during follow-up. The overall procedural success rate was 59.1%. The remaining 22 patients had no combined large-fiber conduction bundle injuries, 39 limbs were successfully treated during follow-up, and five limbs could not be salvaged. Long-term SCS treatment was found to be more likely to be successful in patients without large-fiber bundle injury (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e), as calculated using the LR and a chi-square test (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.007).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOutcome of SCS procedure in all patients based on a 10 g monofilament test\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSuccess\u003c/p\u003e \u003cp\u003e(numbers of limbs)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFailure\u003c/p\u003e \u003cp\u003e(numbers of limbs)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003cp\u003e(numbers of limbs)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e10g-test (-)\u003c/p\u003e \u003cp\u003e(numbers of limbs)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e44\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e10g-test (+)\u003c/p\u003e \u003cp\u003e(numbers of limbs)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003cp\u003e(numbers of limbs)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e66\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eA likelihood ratio chi-square test indicated a significant difference in the success rate of SCS surgery for patients with or without large fiber neuropathy (\u003cem\u003eχ\u003c/em\u003e\u0026thinsp;=\u0026thinsp;7.288, \u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.007).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003e3.4 Predictors of treaetment outcome\u003c/h2\u003e \u003cp\u003eLogistic regression analysis was performed for large-fiber neuropathy, ulcer grade and the △IRT, indicating significant differences in large-fiber neuropathy (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.025) and the △IRT (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.001, SPSS, 23.0). This suggested that large-fiber neuropathy and the △IRT are associated with long-term SCS treatment outcomes (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). However, the two dumb variables in ulcer grade were not statistically significant, indicating that there was no statistical difference between Wagner system grade 0 and Wagner system grade 3\u0026ndash;5; there was no statistical difference between Wagner system grade 1\u0026ndash;2 and Wagner system grade 3\u0026ndash;5.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eLogistic Regression Results\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cem\u003eβ\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e95% confidence interval\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cem\u003eP\u003c/em\u003e\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWagner grade*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e-1.014\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.363(0.034, 3.886)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.402\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWagner grade**\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e-0.836\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.434(0.032, 5.811)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.528\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003elarge-fiber neuropathy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2.128\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e8.394(1.313, 53.661)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.025\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e△IRT\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1.772\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5.883(2.008, 17.231)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eWagner grade* and Wagner grade** represented the first dumb variable and the second dumb variable in ulcer grading variable, respectively.\u003c/p\u003e \u003cp\u003eFor Wagner Grade 3\u0026ndash;5, both dumb variables are 0; for Wagner Grade 1\u0026ndash;2, the first dumb variable is 0 and the second dumb variable is 1; for Wagner Grade 0, the first dumb variable is 1 and the second dumb variable is 0.\u003c/p\u003e \u003cp\u003eTreatment success was considered a positive result.\u003c/p\u003e \u003c/div\u003e"},{"header":"4. DISCUSSION","content":"\u003cp\u003eInfrared radiation is electromagnetic radiation emitted by the human body. Infrared thermal imaging technology generates two-dimensional heat maps through capturing infrared radiation, which is a representative method to visualize temperature distribution\u003csup\u003e[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e. Humans are homeothermic animals, and the skin has a key role in regulating temperature, mainly through autonomic responses, including cutaneous vasomotor and sweating responses\u003csup\u003e[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/sup\u003e. In the extremities of the human body, microcirculatory vessels and their environment have the most significant effects on skin temperature\u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e. IRT has been widely used in clinical practice to reflect microcirculatory blood flow changes through detecting skin temperature and has been reported to predict the prognosis of ulcerated wounds in patients without DM\u003csup\u003e[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]\u003c/sup\u003e. In DM-related diseases, IRT is recommended as a screening tool to assess high-risk DF disease owing to its simplicity, effectiveness, safety, and non-invasiveness\u003csup\u003e[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e. For patients with DF, common long-term complications include microangiopathy and autonomic neuropathy, resulting in the coexistence of ischemic and neuropathic pain, markedly reducing patient quality of life and increasing the risk of amputation\u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e. Currently, the drugs used in clinical practice are mainly used to relieve pain\u003csup\u003e[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/sup\u003e. Previous studies have shown that SCS relieves lower extremity pain; however, a recent randomized controlled trial showed that the long-term analgesic effect of SCS is influenced through the placebo effect and public opinion orientation\u003csup\u003e[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/sup\u003e. It has been reported that patients' perception of pain improvement following SCS treatment decreases with longer implantation times; pain relief is evident at initial implantation due to abnormal sensations resulting from high neuronal charge transfer replacing nociceptive pain\u003csup\u003e[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]\u003c/sup\u003e. However, with prolonged treatment, this abnormal sensation may lead to the patient experiencing discomfort later in life, which could be an adaptive phenomenon in patients with chronic pain\u003csup\u003e[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eFor patients with severe DF, the aim of SCS treatment is both pain relief and limb preservations\u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/sup\u003e. SCS is considered as a second-line treatment modality for painful DM-related peripheral neuropathy\u003csup\u003e[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]\u003c/sup\u003e. SCS has been suggested to relieve ischemic pain through inhibiting pain signaling, leading to reduced sympathetic activity and improved skin microcirculation. One study suggested that spinal cord stimulation suppresses sympathetic autonomic activity and dilates peripheral microcirculatory vessels\u003csup\u003e[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]\u003c/sup\u003e, which was confirmed with skin temperature changes in the IRT responses. It has also been suggested that an improvement in blood flow to the lower extremities may be associated with a reduction in inflammatory responses and an improvement in vascular endothelial function\u003csup\u003e[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e, \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn this study, pain symptoms improved in all patients, the postoperative pain scores of patients in both groups with different treatment results were significantly lower than those taken prior to surgery, and no difference in pain scores was observed at the same stage between the two groups, indicating short-term pain relief post-SCS treatment. Through analyzing the mean values of the △IRT between the treatment success and failure groups, we observed a difference in mean values of the △IRT between the two groups. Specifically, the treatment success group had higher mean postoperative IRT values than those prior to surgery, while the treatment failure group had lower mean postoperative IRT values than those prior to surgery. This difference in the mean values of the △IRT between the two groups may reflect differences in the hemodynamics of an affected limb post-SCS treatment: the mean postoperative IRT value was higher than that of the affected limb prior to surgery and the microcirculation improvement of the affected limb was better than that of the limb without significant change pre- and postoperatively. Further analysis yielded a cut-off value of -0.12 ℃ for the △IRT. This indicated that the affected limb with the △IRT \u0026gt;-0.12\u0026deg;C had a high likelihood of successful treatment and limb salvage. This study\u0026rsquo;s findings showed that the success of treatment was independent of foot ulcer grade. In addition, the prognosis of SCS in patients with DF and large-fiber neuropathy is generally poor, with a surgical success rate of 59.1%, which is lower than the overall surgical success rate of 78.8% found in our study. This may be because neuropathy affects vasomotor responses, leading to reduced benefits in relation to SCS treatment.\u003c/p\u003e \u003cp\u003eIn summary, given the success rate of surgery and the economic cost effect, we consider that patients with DF who have large-fiber neuropathy or the △IRT of \u0026lt;-0.12\u0026deg;C are not suitable candidates for long-term SCS treatment. However, this study had several limitations. The sample size was relatively small, with a single-center retrospective design with the likelihood of some bias. Only six-months treatment effects were observed in this study; the longer-term effects are unknown. Therefore, further studies are required to validate these results. Other objective evaluation indicators such as lower limb artery enhanced CT, lower limb artery ultrasound, and lower limb electromyography could be used to analyze the perioperative changes in the above indicators to obtain a specific risk scoring system or prognostic model.\u003c/p\u003e"},{"header":"5. CONCLUSION","content":"\u003cp\u003eThere are no reliable diagnostic indicators concerning SCS treatment outcomes. We analyzed the mean values of IRT, the severity of peripheral neuropathy, and the status of patients with DF who had undergone SCS treatment before and 1 week after surgery and at the follow-up endpoint. SCS safely and effectively improved the symptoms of lower limb ischemia and pain in patients with different degrees of DF disease and improves patient quality of life. IRT can be used as a diagnostic index for the prognosis of patients with DF receiving SCS and it has moderate diagnostic value. In clinical applications to screen patients suitable for long-term SCS treatment, we recommend that patients with DF who have large-fiber neuropathy or the △IRT \u0026lt;-0.12\u0026deg;C should be treated cautiously with permanent SCS.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eI, Hongyu Qu, declare that there are no conflicts of interest in relation to the manuscript titled \u0026quot;Spinal Cord Stimulation in Patients with Diabetic Foot Disease: Prognosis Determined using Infrared Thermography as a Diagnostic Test\u0026quot; submitted to Journal of Nondestructive Evaluation.\u003c/p\u003e\n\u003cp\u003eI confirm that the results and interpretations reported in the manuscript are original and have not been plagiarized. I certify that I have read and understand the Journal of Nondestructive Evaluation conflict of interest policy, and I understand that failure to disclose a conflict of interest may result in the manuscript being rejected or retracted.\u003c/p\u003e\n\u003cp\u003eI also certify that I have disclosed any financial or non-financial relationships that may be interpreted as constituting a conflict of interest in relation to this manuscript. I understand that this information will be subject to peer review, and I am willing to provide further information or clarification if required.\u003c/p\u003e\n\u003cp\u003eI confirm that I have no known conflicts of interest that would influence the results or interpretation of the data presented in this manuscript, and I understand that failure to disclose a conflict of interest is unethical and may result in sanctions being imposed on me.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eM.B. and M.Z. designed the study. H.Q. collected and analyzed the data of patients, M.B. provided technical support. M.Z. and H.Q. wrote the manuscript. All authors reviewed the manuscript.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eData is provided within the manuscript or supplementary information files\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eDe Vries, J., De Jongste, M.J., Spincemaille, G., Staal, M.J.: Spinal cord stimulation in ischemic heart and peripheral vascular disease. AdvTech Stand Neurosurg. ;32:63\u0026ndash;89. (2007). \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1007/978-3-211-47423-5_4\u003c/span\u003e\u003cspan address=\"10.1007/978-3-211-47423-5_4\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. 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PMID: 22151202\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTaylor, R.S., Ryan, J., O'Donnell, R., Eldabe, S., Kumar, K., North, R.B.: The cost-effectiveness of spinal cord stimulation in the treatment of failed back surgery syndrome. Clin J Pain. (2010). Jul-Aug;26(6):463-9 \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/AJP.0b013e3181daccec\u003c/span\u003e\u003cspan address=\"10.1097/AJP.0b013e3181daccec\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. PMID: 20551721\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"diabetic foot, infrared thermography, lower limb ischemia, neuropathy, spinal cord stimulation","lastPublishedDoi":"10.21203/rs.3.rs-4935489/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4935489/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eWe aimed to determine whether perioperative infrared thermography (IRT) could be used as an index of success in the treatment of spinal cord stimulation (SCS) in patients with diabetic foot (DF) disease and in selecting suitable candidates for long-term SCS.\u003c/p\u003e\u003ch2\u003eMETHODS\u003c/h2\u003e \u003cp\u003e Thirty-three patients with DF meeting our study inclusion criteria underwent permanent SCS implantation at the Shengjing Hospital of China Medical University from January 2021 to August 2023. Patients were grouped preoperatively based on the Wagner grading system for DF ulcers, and peripheral neuropathy was tested using a 10 g monofilament. The patients underwent temporary SCS following acompleting routine preoperative examination. IRT was performed preoperatively and at 1 week postoperatively, while lower limb skin temperature was recorded at multiple points and the mean value was calculated. During the temporary SCS test, patient pain was relieved satisfactorily; therefore, all patients subsequently underwent permanent SCS implantation and participated in a 6-month follow-up, with no complications leading to device removal. The patients were divided into two groups according to limb salvage status (treatment success group, no minor or major amputation during the follow-up postoperative period; treatment failure group, minor or major amputation performed during the follow-up period). To evaluate whether there were differences in patient baseline clinical data and the success rate of surgery according to different Wagner ulcer grades, a receiver operating characteristic curve was used to analyze the indicators of IRT. Logistic regression analysis was performed for large-fiber neuropathy, ulcer grade and the preoperative IRT.\u003c/p\u003e\u003ch2\u003eRESULTS\u003c/h2\u003e \u003cp\u003eAll patients received permanent SCS and were followed up for 6 months. All patients had different degrees of pain relief (preoperative visual analog score [VAS], 6.82\u0026thinsp;\u0026plusmn;\u0026thinsp;1.32; postoperative VAS, 5.48\u0026thinsp;\u0026plusmn;\u0026thinsp;1.18; \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Fifty-two limbs were salvaged during the follow-up period (SCS success rate, 78.8%). No significant difference in the SCS success rate in the affected limbs was observed between the different Wagner ulcer groups (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.293). In the treatment success group, the mean preoperative IRT temperature was 31.35\u0026thinsp;\u0026plusmn;\u0026thinsp;1.92\u0026deg;C, the mean postoperative IRT temperature was 31.99\u0026thinsp;\u0026plusmn;\u0026thinsp;1.86\u0026deg;C, and the mean lower limb skin temperature increased by 0.65\u0026deg;C. In the treatment failure group, the mean preoperative IRT temperature in the lower limbs was 32.38\u0026thinsp;\u0026plusmn;\u0026thinsp;2.25\u0026deg;C, and the mean IRT temperature at 1 week postoperatively was 31.69\u0026thinsp;\u0026plusmn;\u0026thinsp;1.78\u0026deg;C, showing a decrease of 0.70\u0026deg;C. The SCS success rate was 59.1% in limbs with large-fiber neuropathy, and 88.6% in limbs without large-fiber neuropathy, and the difference was statistically significant (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.007). We calculated the difference between perioperative IRT temperatures in the same limb and compared mean pre- and postoperative IRT temperatures. The diagnostic threshold for IRT alone was \u0026minus;\u0026thinsp;0.12\u0026deg;C, i.e., a -0.12\u0026deg;C increase postoperatively compared with preoperatively (positive predictive value, 91.84%; negative predictive value, 58.82%; AUC\u003csub\u003eIRT\u003c/sub\u003e, 0.79 [0.63\u0026ndash;0.95], \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Combined large-fiber neuropathy (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.025) and the difference in perioperative IRT mean values (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.001) were statistically significant for the diagnosis of SCS treatment results.\u003c/p\u003e\u003ch2\u003eCONCLUSION\u003c/h2\u003e \u003cp\u003eSCS treatment effectively relieved lower limb pain. Patients with DF and large fiber neuropathy had a lower surgical success rate, IRT was significantly higher in the treatment success group, and patients with peripheral neuropathy or a mean increase in perioperative lower limb IRT temperatures of \u0026lt;\u0026thinsp;\u0026minus;\u0026thinsp;0.12\u0026deg;C were not suitable candidates for long-term SCS. IRT can be used as a diagnostic index for the prognosis of patients with DF receiving SCS and select suitable long-term SCS treatment candidates.\u003c/p\u003e","manuscriptTitle":"Spinal Cord Stimulation in Patients with Diabetic Foot Disease: Prognosis Determined using Infrared Thermography as a Diagnostic Test","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-10-14 12:12:14","doi":"10.21203/rs.3.rs-4935489/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ba567cf5-8c03-47af-837e-11ecf674a5cc","owner":[],"postedDate":"October 14th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-04-25T06:23:48+00:00","versionOfRecord":[],"versionCreatedAt":"2024-10-14 12:12:14","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4935489","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4935489","identity":"rs-4935489","version":["v1"]},"buildId":"zQwnuV7TCBrMSSSToR1PI","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}