Clinical outcomes of early revascularization in severe diabetic foot ulcer with ischemia: a single center experience

Clinical outcomes of early revascularization in severe diabetic foot ulcer with ischemia: a single center experience | 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 Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Clinical outcomes of early revascularization in severe diabetic foot ulcer with ischemia: a single center experience Arash Mohammadi Tofigh, Majid Samsami, Alireza Haghbin Toutounchi, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5060078/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: The effect of early revascularization on preventing amputation of diabetic foot ulcers (DFU) patients is challenging. This study aimed to evaluate the impact of early revascularization in ischemic severe DFU outcomes. Methods: This prospective cohort study was conducted on 30 patients with severe DFU (Wound Wagner grade 4 and 5), and peripheral artery disease referred to Imam Hossein Hospital in Tehran, Iran, from April 2020 to March 2022. All patients underwent lower limb vascular surgery. Patients were examined for 20 months regarding wound healing, amputation, and death. Data were analyzed by SPSS statistic version 27. Results: The present study included 30 patients (30 lower limbs). The mean time of patients’ follow-up to outcome was 12.56 (SD=4.36, 3-20) months. The mean wait time to revascularization was 8.90 (SD= 2.32, 6-15) weeks. Nine patients (30%) waited more than nine weeks for revascularization. Totally 14 patients (46.7%) healed without major amputation. A shorter time to revascularization (9 weeks and less) was significantly related to a higher probability of healing without major amputation over time (P value= 0.017). Conclusion: The results of the present study showed that shorter waiting time for vascular intervention in patients with severe DFU and ischemia is related to wound healing in patients without the need for major amputation. It seems necessary to conduct more studies about the time of vascular intervention in this group of patients. General Surgery Vascular Medicine Cardiac & Cardiovascular Systems Endocrinology & Metabolism Early revascularization Diabetic foot ulcer Angioplasty Ischemia peripheral artery disease Figures Figure 1 Introduction Diabetes is a type of metabolic disorder and one of the most common endocrine diseases and the most common cause of death worldwide ( 1 ). This disease is associated with hyperglycemia caused by defects in insulin function, secretion, or both, and causes abnormal metabolism of carbohydrates, proteins, and fats ( 2 ). There are more than 415 million diabetic patients worldwide ( 3 ), estimated to reach 552 and 642 million by 2030 and 2040, respectively ( 3 – 6 ). Iran has about 5 million patients with diabetes ( 2 ), and its annual growth rate is estimated to reach second place in the Middle East after Pakistan by 2030 ( 3 ). Diabetes causes many complications in body organs, including vasculopathy, nephropathy, neuropathy, and retinopathy ( 7 ). Despite these complications, diabetic foot ulcers (DFU) are one of the most common ( 8 , 9 ), serious, and costly complications of diabetes, which increases the mortality risk of diabetic patients by two to four times ( 10 ). Approximately 15 percent of diabetic patients will suffer from DFU during their lifetime ( 11 ). According to the World Health Organization (WHO), a DFU is an infection, wound, or soft tissue destruction due to neurological and peripheral vascular abnormalities in the lower limbs ( 12 ). Vasculopathy is one of the most common causes of DFU, which exists in 20–30% of diabetic patients, and more than 40% of people with vasculopathy develop DFU ( 13 ). DFU treatment is included antibiotics therapy with or without the debridement of infected tissue and amputation. Most diabetic ulcers require surgery, but unfortunately, in some patients, amputation is the best treatment option ( 14 ). Amputations caused by ischemia due to peripheral artery disease (PAD) in patients with DFU result in a loss of their quality of life ( 15 ). The primary purpose of ischemic DFU management is to reduce amputation, significantly impacting patients’ performance and quality of life ( 16 ). Revascularization is one of the most effective procedures in preventing amputation by increasing blood supply and allowing wound healing ( 15 ). Revascularization is an effective procedure for treating DFU and should be considered in patients who didn't respond to other medical management ( 17 ). The safety and effectiveness of revascularization in DFU and limb ischemia have been well established, while its clinical outcomes remain challenging ( 18 – 20 ). If a diabetic patient with an ischemic foot ulcer does not show signs of improvement after six weeks of appropriate non-invasive treatment, vascular imaging, and possible revascularization should be considered ( 21 , 22 ). However, data on the impact of revascularization wait times on diabetic foot ulcer outcomes, especially in patients with severe ulcers, is extremely scarce. So this study aimed to evaluate the clinical effects of early revascularization in patients with severe DFU with PAD. Methods Study Design and Participants This prospective cohort study was conducted on 30 patients with severe DFU and PAD (peripheral artery disease) referred to Imam Hossein Hospital in Tehran, Iran, from April 2020 to March 2022. The tents of the Declaration of Helsinki conducted the research. This study resulted from a research project with an Ethical code (IR.SBMU.MSP.REC.1401.032) approved by the ethics committee of Shahid Beheshti University of Medical Sciences, Tehran, Iran. All patients completed the written ethical consent to participate in the study and were included based on the inclusion and exclusion criteria. The inclusion criteria included age more than 18 years, diabetes mellitus, severe DFU, and PAD lesions (Wagner grade 4–5, at or below the ankle, Fontaine grade 4, and ABI (Ankle-brachial index) < 0.80), ischemic foot ulcer does not show signs of improvement after six weeks of appropriate non-invasive treatment and an indication of surgical revascularization (PTA was not possible or not successful). The exclusion criteria included acute limb ischemia and non-atherosclerotic chronic vascular conditions of the lower extremity. A surgeon treated all patients, and the patients were under standard supportive treatments (dressing and wound treatment) along with the required antibiotic treatment according to the opinion of the infectious disease specialist. Vascular intervention The decision for revascularization was taken by the vascular surgeon based on the ulcer characteristics, findings of peripheral pressure measurements, and the response to the given conservative management. In each case, a diagnostic duplex ultrasound (DUS) was performed as part of the preoperative and post-operative evaluation process. The distal flow was improved through a variety of procedures. The most common surgical procedure involved a bypass either above or below the knee (including ultra-distal bypasses); the endovascular approach was used for short femoropopliteal lesions or involvement of arteries below the knee; and a Hybrid Therapy (HT) was implemented when a significant impairment of the common femoral artery or multilevel vascular disease was present, and a direct surgical or endovascular procedure would not have been enough. Data Collection Demographic characteristics included age, gender, body mass index (BMI), underlying diseases, medications, duration of diabetes, and revascularization wait times (Time between patient referred to diabetic foot center and vascular intervention) were collected. The time to revascularization was calculated from the first presentation at the diabetic foot center since the time from the onset of the ulcer was often unknown. Wound Wagner grade and WIFI classification were assessed and recorded before revascularization. Clinical outcomes included wound healing, foot amputation (major and minor) after revascularization, and mortality, which patients were followed until healing or death for a maximum of 20 months. Major amputation was defined as any amputation performed above the ankle level, and minor amputation was defined as any amputation at the level of or below the ankle. Statistical analysis Data were analyzed by SPSS statistic version 27 (IBM corporation, New York, NY, USA). Quantitative variables were conducted to describe the data center means, and standard deviations were used to describe the data distribution. For data normality, the Shapiro-Wilk test was used. Comparisons between groups were made using the independent T or chi-square test. Univariate survival analysis of variables was done using Kaplan–Meier analysis, where a log-rank test determined statistical significance. In all analyses, p-value less than 0.05 were considered significant. Results The present study included 30 patients (30 lower limbs). Demographic information of patients and disease records, along with revascularization wait times and examinations of the involved organs in terms of ulcer and ischemia, are shown in Table 1 . The mean time of patients’ follow-up to outcome was 12.56 (SD = 4.36, 3–20) months. The mean wait time to revascularization was 8.90 (SD = 2.32, 6–15) weeks. Nine patients (30%) waited more than nine weeks for revascularization. Out of 30 patients, 20 (67.7%) were healed. Out of 30 patients, nine patients (30%) healed after minor amputation, 6 (20%) healed after major amputation, 5 (16.7%) healed primarily, and 10 (33.3%) unhealed or died unhealed during follow-up. Totally 14 patients (46.7%) healed without major amputation. Clinical characteristics of patients at inclusion based on outcome compared in Table 2 . There was no significant difference between variables based on outcome (healed without major amputation versus healed with major amputation, unhealed, or died). A shorter time to revascularization (9 weeks or less) was significantly related to a higher probability of healing without major amputation over time (P value = 0.017) (Fig. 1 ). Table 1 Clinical characteristics of patients at inclusion. Variables Mean (SD) Age (years) 58.76 (8.24) BMI (kg/m 2 ) 26.88 (2.29) Diabetes duration (years) 15.23 (4.43) HbA1c (%) 7.97 (0.75) Variables n (%) Gender (male) 16 (53.3%) IHD 11 (36.7%) HF 5 (16.7%) CVD 6 (20%) Diabetes medications : Only Insulin Oral Hypoglycemic Medications + insulin Only oral Hypoglycemic Medications 15 (50%) 7 (23.3%) 8 (26.7%) Wound Wagner grade : 4 5 17 (56.7%) 13 (43.3%) WIFI classification Wound : Moderate Severe Ischemia : Mild Moderate Severe Foot infection : Mild Moderate Clinical stage : 4 17 (56.7%) 13 (43.3%) 1 (3.3%) 17 (56.7%) 12 (40%) 16 (53.3%) 14 (46.7%) 30 (100%) BMI: Body mass index, IHD: Ischemic heart disease, HF: Heart failure, CVD: Cerebrovascular disease. Table 2 Clinical characteristics of patients at inclusion based on outcome. Healed without major amputation (14) Healed with major amputation or unhealed and died (16) Variables Mean (SD) Mean (SD) P value* Age (years) 57.57 (7.73) 59.81 (8.76) 0.467 BMI (kg/m 2 ) 26.45 (2.48) 27.26 (2.13) 0.344 Diabetes duration (years) 14.07 (3.56) 16.26 (4.97) 0.184 HbA1c (%) 7.87 (0.75) 8.06 (0.77) 0.487 Variables n (%) n (%) P value^ Gender (male) 9 (64.3%) 7 (43.8%) 0.299 IHD 6 (42.9%) 5 (31.3%) 0.707 CHF 2 (14.3%) 3 (18.8%) 0.999 CVD 3 (21.4%) 3 (18.8%) 0.999 Diabetes medications : Only Insulin Oral Hypoglycemic Medications + insulin Only oral Hypoglycemic Medications 7 (50%) 5 (35.7%) 2 (14.3%) 8 (50%) 2 (12.5%) 6 (37.5%) 0.220 Wound Wagner grade : 4 5 8 (57.1%) 6 (42.9%) 9 (56.3%) 7 (43.8%) 0.999 WIFI classification Wound : Moderate Severe Ischemia : Mild Moderate Severe Foot infection : Mild Moderate 8 (57.1%) 6 (42.9%) 0 (0%) 9 (64.3%) 5 (35.7%) 9 (64.3%) 5 (35.7%) 9 (56.3%) 7 (43.8%) 1 (6.3%) 8 (50%) 7 (43.8%) 7 (43.8%) 9 (56.3%) 0.999 0.846 0.299 *: Independent-T test, ^: Fisher’s exact test. BMI: Body mass index, IHD: Ischemic heart disease, HF: Heart failure, CVD: Cerebrovascular disease. Discussion Patients with diabetes often have a vascular disease associated with atherosclerotic multilevel conditions affecting multiple arterial segments and organs and necessitating careful evaluation of all associated complications. Therefore, dialectologists, internists, and surgeons should collaborate aggressively to coordinate revascularization procedures, treat infections, and manage medical comorbidities associated with DFU, as it is a significant disease requiring multidisciplinary consensus. The risk of PAD and subsequent amputation is five to ten times higher in patients with diabetes than in those without diabetes, and the risk increases by 26% for every 1% increase in hemoglobin A1c level, as reported in several reviews ( 23 – 26 ). This study aimed to determine how early revascularization in patients with severe DFU and PAD affected their clinical outcomes. However, there is a severe lack of information regarding the effect of revascularization wait times on the outcomes of diabetic foot ulcers, particularly in patients with severe DFU. According to this study's findings, there was no significant difference between the variables based on the outcome (healed without major amputation, healed with major amputation, unhealed, or died). There was a significant correlation between a shorter time to revascularization (nine weeks or less) and a higher probability of healing without major amputation. The study of Elgzyri et al. ( 21 ) showed that the time to vascular intervention within eight weeks, maximum Wagner grade reached < 3, absence of peripheral edema, and presence of intermittent claudication were related to a higher probability of healing that is in line with present study findings. Together, this finding and the one that time to revascularization affects outcome suggest that patients with diabetes and ischemic foot ulcer, despite the presence of pain or the extent of wound and tissue destruction, should be considered for invasive revascularization as soon as possible. On the other hand, according to the findings of the present study, in patients with severe DFU (Wegener's wound grade 4 and 5) and ischemia, the earlier vascular intervention was associated with wound healing without the need for major amputation, which shows the importance of time in the treatment of this group of patients. The most important point of strength of the present study was to investigate the effect of vascular intervention time in patients with severe DFU and ischemia. The most important limitation of the present study can be the limitation in the sample size due to conducting the study in a single center to identify other factors affecting wound healing in patients. In this context, an attempt was made to investigate the effect of vascular intervention time on wound healing in a specific group of patients with severe DFU. Conclusion The results of the present study showed that shorter waiting time for vascular intervention in patients with severe DFU and ischemia is related to wound healing in patients without the need for major amputation. It is necessary to conduct more studies on the relationship between the time of vascular intervention in this group of patients. Declarations Funding: The authors declare that no funds, grants, or other support were received during the preparation of this manuscript. Competing Interest: The authors have no relevant financial or non-financial interests to disclose. Ethical Approval: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the University of Medical Sciences. Informed consent: Informed consent was obtained from all individual participants included in the study. Data availability: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request. Author contribution: Dr. Arash Mohammadi Tofigh, participated in Supervision and validation. Dr. Majid Samsami, participated in Conceptualization and analysis. Dr. Alireza Haghbin Toutounchi, participated in Methodology and Writing - Review & Editing. Dr. Seyed Pedram Kouchak Hosseini, participated in Writing- Original draft and Visualization. Dr. Hojatolah Khoshnoudi, participated in Term and Data curation. Dr. Soheil Bagherian Lemraski: Project administration, corresponding author. References Rong F, Dai H, Wu Y, Li J, Liu G, Chen H, et al. Association between thyroid dysfunction and type 2 diabetes: a meta-analysis of prospective observational studies. BMC Med. 2021;19(1):257. Nasim K, Saeed B, Maryam E, Shiva B. Evaluation of Thyroid Function in Patients with Type II Diabetes during 2019-2021. Evaluation. 2022;10(3):2423-5571. Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010;87(1):4-14. Whiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011;94(3):311-21. Guariguata L. By the numbers: new estimates from the IDF Diabetes Atlas Update for 2012. Diabetes Res Clin Pract. 2012;98(3):524-5. Tudor RM, Garrahy A, Woods CP, Crowley RK, Tormey WT, Smith D, et al. The prevalence and incidence of thyroid dysfunction in patients with diabetes - a longitudinal follow-up study. Ir J Med Sci. 2020;189(1):171-5. Shi L, Shu XO, Li H, Cai H, Liu Q, Zheng W, et al. Physical activity, smoking, and alcohol consumption in association with incidence of type 2 diabetes among middle-aged and elderly Chinese men. PLoS One. 2013;8(11):e77919. Ogbonna SU, Ezeani IU. Risk Factors of Thyroid Dysfunction in Patients With Type 2 Diabetes Mellitus. Front Endocrinol (Lausanne). 2019;10:440. Aliabadi DA, Moradian N, Rahmanian E, Mohammadi M. Prevalence of neuropathy in patients with type 2 diabetes in Iran : A systematic review and meta-analysis. Wien Klin Wochenschr. 2021;133(5-6):222-8. Yekta Z, Pourali R, Ghasemi-Rad M. Comparison of demographic and clinical characteristics influencing health-related quality of life in patients with diabetic foot ulcers and those without foot ulcers. Diabetes Metab Syndr Obes. 2011;4:393-9. Tabatabaei Malazy O, Mohajeri-Tehrani MR, Pajouhi M, Shojaei Fard A, Amini MR, Larijani B. Iranian Diabetic Foot Research Network. Adv Skin Wound Care. 2010;23(10):450-4. Aalaa M, Malazy OT, Sanjari M, Peimani M, Mohajeri-Tehrani M. Nurses' role in diabetic foot prevention and care; a review. J Diabetes Metab Disord. 2012;11(1):24. Alikhani A, Moradi M, Alikhani S. Epidemiological study, risk factors and clinical outcomes of diabetic foot infection in hospitalized patients. Journal of Mazandaran University of Medical Sciences. 2015;25(129):81-91. Lipsky BA, Berendt AR, Deery HG, Embil JM, Joseph WS, Karchmer AW, et al. Diagnosis and treatment of diabetic foot infections. Clinical infectious diseases. 2004;39(7):885-910. Houlind K. Surgical revascularization and reconstruction procedures in diabetic foot ulceration. Diabetes/Metabolism Research and Reviews. 2020;36(s1):e3256. Wendling S, Beadle V. The relationship between self-efficacy and diabetic foot self-care. J Clin Transl Endocrinol. 2015;2(1):37-41. Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev. 2020;36 Suppl 1:e3266. Odink H, van den Berg A, Winkens B. Technical and clinical long-term results of infrapopliteal percutaneous transluminal angioplasty for critical limb ischemia. J Vasc Interv Radiol. 2012;23(4):461-7, 7.e1. Peregrin JH, Koznar B, Kovác J, Lastovicková J, Novotný J, Vedlich D, et al. PTA of infrapopliteal arteries: long-term clinical follow-up and analysis of factors influencing clinical outcome. Cardiovasc Intervent Radiol. 2010;33(4):720-5. Hinchliffe RJ, Forsythe RO, Apelqvist J, Boyko EJ, Fitridge R, Hong JP, et al. Guidelines on diagnosis, prognosis, and management of peripheral artery disease in patients with foot ulcers and diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020;36 Suppl 1:e3276. Elgzyri T, Larsson J, Nyberg P, Thörne J, Eriksson KF, Apelqvist J. Early Revascularization after Admittance to a Diabetic Foot Center Affects the Healing Probability of Ischemic Foot Ulcer in Patients with Diabetes. European Journal of Vascular and Endovascular Surgery. 2014;48(4):440-6. Apelqvist J, Lepäntalo M. The ulcerated leg: when to revascularize. Diabetes/metabolism research and reviews. 2012;28:30-5. Dinoto E, Ferlito F, La Marca MA, Tortomasi G, Urso F, Evola S, et al. The Role of Early Revascularization and Biomarkers in the Management of Diabetic Foot Ulcers: A Single Center Experience. Diagnostics (Basel). 2022;12(2). Olinic DM, Spinu M, Olinic M, Homorodean C, Tataru DA, Liew A, et al. Epidemiology of peripheral artery disease in Europe: VAS Educational Paper. Int Angiol. 2018;37(4):327-34. Lepäntalo M, Apelqvist J, Setacci C, Ricco JB, de Donato G, Becker F, et al. Chapter V: Diabetic foot. Eur J Vasc Endovasc Surg. 2011;42 Suppl 2:S60-74. Bracale UM, Ammollo RP, Hussein EA, Hoballah JJ, Goeau-Brissonniere O, Taurino M, et al. Managing Peripheral Artery Disease in Diabetic Patients: A Questionnaire Survey from Vascular Centers of the Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS). Ann Vasc Surg. 2020;64:239-45. Additional Declarations The authors declare no competing interests. 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 Advisory Board 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-5060078","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":351701337,"identity":"dd7b82fa-72c8-46ed-9e1a-ac60ef9a6f0a","order_by":0,"name":"Arash Mohammadi Tofigh","email":"","orcid":"https://orcid.org/0000-0002-3712-0650","institution":"Shahid Beheshti University of Medical Sciences","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Arash","middleName":"Mohammadi","lastName":"Tofigh","suffix":""},{"id":351701338,"identity":"321cd9d5-4d73-4eac-a50d-4a0325d2e081","order_by":1,"name":"Majid Samsami","email":"","orcid":"https://orcid.org/0000-0003-0832-9567","institution":"Shahid Beheshti University of Medical Sciences","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Majid","middleName":"","lastName":"Samsami","suffix":""},{"id":351701339,"identity":"e6576714-2416-4c4f-86bb-c6393d90e964","order_by":2,"name":"Alireza Haghbin Toutounchi","email":"","orcid":"https://orcid.org/0000-0002-5446-6346","institution":"Shahid Beheshti University of Medical Sciences","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Alireza","middleName":"Haghbin","lastName":"Toutounchi","suffix":""},{"id":351701340,"identity":"e236dd58-d059-403d-9f8d-a186468fe9eb","order_by":3,"name":"Seyed Pedram Kouchak Hosseini","email":"","orcid":"https://orcid.org/0000-0003-2603-3372","institution":"Shahid Beheshti University of Medical Sciences","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Seyed","middleName":"Pedram Kouchak","lastName":"Hosseini","suffix":""},{"id":351701341,"identity":"6b68a79f-70e2-41e7-b3de-5e157f445b86","order_by":4,"name":"Hojatolah Khoshnoudi","email":"","orcid":"https://orcid.org/0009-0009-7518-9825","institution":"Shahid Beheshti University of Medical Sciences","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Hojatolah","middleName":"","lastName":"Khoshnoudi","suffix":""},{"id":351701342,"identity":"189e8284-e6b8-4fc1-b342-041f1560edb1","order_by":5,"name":"Soheil Bagherian Lemraski","email":"data:image/png;base64,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","orcid":"https://orcid.org/0000-0002-8789-5809","institution":"Artesh University of Medical Sciences","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Soheil","middleName":"Bagherian","lastName":"Lemraski","suffix":""}],"badges":[],"createdAt":"2024-09-09 19:07:54","currentVersionCode":1,"declarations":{"humanSubjects":true,"vertebrateSubjects":false,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":true,"humanSubjectConsent":true,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":false,"coiExplicitlySet":false},"doi":"10.21203/rs.3.rs-5060078/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5060078/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":64285606,"identity":"2795b420-0f11-4652-9aa5-b62dbc331108","added_by":"auto","created_at":"2024-09-11 08:41:25","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":30709,"visible":true,"origin":"","legend":"\u003cp\u003eProbability of ulcer healing without major amputation in relation to time to revascularization (Kaplan–Meier analysis).\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5060078/v1/ba8d1132d9a5ce9eed669baf.png"},{"id":64285607,"identity":"e509ca1f-b8c2-41e8-82fc-ac1ebb465c27","added_by":"auto","created_at":"2024-09-11 08:41:29","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":527782,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5060078/v1/ba2d3391-a200-496f-8d11-01ab008a8fb5.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eClinical outcomes of early revascularization in severe diabetic foot ulcer with ischemia: a single center experience\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eDiabetes is a type of metabolic disorder and one of the most common endocrine diseases and the most common cause of death worldwide (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). This disease is associated with hyperglycemia caused by defects in insulin function, secretion, or both, and causes abnormal metabolism of carbohydrates, proteins, and fats (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). There are more than 415\u0026nbsp;million diabetic patients worldwide (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e), estimated to reach 552 and 642\u0026nbsp;million by 2030 and 2040, respectively (\u003cspan additionalcitationids=\"CR4 CR5\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Iran has about 5\u0026nbsp;million patients with diabetes (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e), and its annual growth rate is estimated to reach second place in the Middle East after Pakistan by 2030 (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eDiabetes causes many complications in body organs, including vasculopathy, nephropathy, neuropathy, and retinopathy (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). Despite these complications, diabetic foot ulcers (DFU) are one of the most common (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e), serious, and costly complications of diabetes, which increases the mortality risk of diabetic patients by two to four times (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Approximately 15 percent of diabetic patients will suffer from DFU during their lifetime (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e). According to the World Health Organization (WHO), a DFU is an infection, wound, or soft tissue destruction due to neurological and peripheral vascular abnormalities in the lower limbs (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Vasculopathy is one of the most common causes of DFU, which exists in 20\u0026ndash;30% of diabetic patients, and more than 40% of people with vasculopathy develop DFU (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). DFU treatment is included antibiotics therapy with or without the debridement of infected tissue and amputation. Most diabetic ulcers require surgery, but unfortunately, in some patients, amputation is the best treatment option (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Amputations caused by ischemia due to peripheral artery disease (PAD) in patients with DFU result in a loss of their quality of life (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). The primary purpose of ischemic DFU management is to reduce amputation, significantly impacting patients\u0026rsquo; performance and quality of life (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Revascularization is one of the most effective procedures in preventing amputation by increasing blood supply and allowing wound healing (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). Revascularization is an effective procedure for treating DFU and should be considered in patients who didn't respond to other medical management (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe safety and effectiveness of revascularization in DFU and limb ischemia have been well established, while its clinical outcomes remain challenging (\u003cspan additionalcitationids=\"CR19\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). If a diabetic patient with an ischemic foot ulcer does not show signs of improvement after six weeks of appropriate non-invasive treatment, vascular imaging, and possible revascularization should be considered (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). However, data on the impact of revascularization wait times on diabetic foot ulcer outcomes, especially in patients with severe ulcers, is extremely scarce. So this study aimed to evaluate the clinical effects of early revascularization in patients with severe DFU with PAD.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design and Participants\u003c/h2\u003e \u003cp\u003eThis prospective cohort study was conducted on 30 patients with severe DFU and PAD (peripheral artery disease) referred to Imam Hossein Hospital in Tehran, Iran, from April 2020 to March 2022. The tents of the Declaration of Helsinki conducted the research. This study resulted from a research project with an Ethical code (IR.SBMU.MSP.REC.1401.032) approved by the ethics committee of Shahid Beheshti University of Medical Sciences, Tehran, Iran. All patients completed the written ethical consent to participate in the study and were included based on the inclusion and exclusion criteria. The inclusion criteria included age more than 18 years, diabetes mellitus, severe DFU, and PAD lesions (Wagner grade 4\u0026ndash;5, at or below the ankle, Fontaine grade 4, and ABI (Ankle-brachial index)\u0026thinsp;\u0026lt;\u0026thinsp;0.80), ischemic foot ulcer does not show signs of improvement after six weeks of appropriate non-invasive treatment and an indication of surgical revascularization (PTA was not possible or not successful). The exclusion criteria included acute limb ischemia and non-atherosclerotic chronic vascular conditions of the lower extremity. A surgeon treated all patients, and the patients were under standard supportive treatments (dressing and wound treatment) along with the required antibiotic treatment according to the opinion of the infectious disease specialist.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eVascular intervention\u003c/h2\u003e \u003cp\u003eThe decision for revascularization was taken by the vascular surgeon based on the ulcer characteristics, findings of peripheral pressure measurements, and the response to the given conservative management. In each case, a diagnostic duplex ultrasound (DUS) was performed as part of the preoperative and post-operative evaluation process. The distal flow was improved through a variety of procedures. The most common surgical procedure involved a bypass either above or below the knee (including ultra-distal bypasses); the endovascular approach was used for short femoropopliteal lesions or involvement of arteries below the knee; and a Hybrid Therapy (HT) was implemented when a significant impairment of the common femoral artery or multilevel vascular disease was present, and a direct surgical or endovascular procedure would not have been enough.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eData Collection\u003c/h2\u003e \u003cp\u003eDemographic characteristics included age, gender, body mass index (BMI), underlying diseases, medications, duration of diabetes, and revascularization wait times (Time between patient referred to diabetic foot center and vascular intervention) were collected. The time to revascularization was calculated from the first presentation at the diabetic foot center since the time from the onset of the ulcer was often unknown. Wound Wagner grade and WIFI classification were assessed and recorded before revascularization. Clinical outcomes included wound healing, foot amputation (major and minor) after revascularization, and mortality, which patients were followed until healing or death for a maximum of 20 months. Major amputation was defined as any amputation performed above the ankle level, and minor amputation was defined as any amputation at the level of or below the ankle.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eData were analyzed by SPSS statistic version 27 (IBM corporation, New York, NY, USA). Quantitative variables were conducted to describe the data center means, and standard deviations were used to describe the data distribution. For data normality, the Shapiro-Wilk test was used. Comparisons between groups were made using the independent T or chi-square test. Univariate survival analysis of variables was done using Kaplan\u0026ndash;Meier analysis, where a log-rank test determined statistical significance. In all analyses, p-value less than 0.05 were considered significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eThe present study included 30 patients (30 lower limbs). Demographic information of patients and disease records, along with revascularization wait times and examinations of the involved organs in terms of ulcer and ischemia, are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The mean time of patients\u0026rsquo; follow-up to outcome was 12.56 (SD\u0026thinsp;=\u0026thinsp;4.36, 3\u0026ndash;20) months. The mean wait time to revascularization was 8.90 (SD\u0026thinsp;=\u0026thinsp;2.32, 6\u0026ndash;15) weeks. Nine patients (30%) waited more than nine weeks for revascularization.\u003c/p\u003e \u003cp\u003eOut of 30 patients, 20 (67.7%) were healed. Out of 30 patients, nine patients (30%) healed after minor amputation, 6 (20%) healed after major amputation, 5 (16.7%) healed primarily, and 10 (33.3%) unhealed or died unhealed during follow-up. Totally 14 patients (46.7%) healed without major amputation. Clinical characteristics of patients at inclusion based on outcome compared in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. There was no significant difference between variables based on outcome (healed without major amputation versus healed with major amputation, unhealed, or died). A shorter time to revascularization (9 weeks or less) was significantly related to a higher probability of healing without major amputation over time (P value\u0026thinsp;=\u0026thinsp;0.017) (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\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\u003eClinical characteristics of patients at inclusion.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariables\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean (SD)\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=\"left\" colname=\"c2\"\u003e \u003cp\u003e58.76 (8.24)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI (kg/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26.88 (2.29)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiabetes duration (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e15.23 (4.43)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHbA1c (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7.97 (0.75)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eVariables\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003en (%)\u003c/b\u003e\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=\"left\" colname=\"c2\"\u003e \u003cp\u003e16 (53.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIHD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (36.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHF\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (16.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCVD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (20%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDiabetes medications\u003c/b\u003e:\u003c/p\u003e \u003cp\u003eOnly Insulin\u003c/p\u003e \u003cp\u003eOral Hypoglycemic Medications\u0026thinsp;+\u0026thinsp;insulin\u003c/p\u003e \u003cp\u003eOnly oral Hypoglycemic Medications\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e15 (50%)\u003c/p\u003e \u003cp\u003e7 (23.3%)\u003c/p\u003e \u003cp\u003e8 (26.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWound Wagner grade\u003c/b\u003e:\u003c/p\u003e \u003cp\u003e4\u003c/p\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17 (56.7%)\u003c/p\u003e \u003cp\u003e13 (43.3%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWIFI classification\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003eWound\u003c/b\u003e:\u003c/p\u003e \u003cp\u003eModerate\u003c/p\u003e \u003cp\u003eSevere\u003c/p\u003e \u003cp\u003e\u003cb\u003eIschemia\u003c/b\u003e:\u003c/p\u003e \u003cp\u003eMild\u003c/p\u003e \u003cp\u003eModerate\u003c/p\u003e \u003cp\u003eSevere\u003c/p\u003e \u003cp\u003e\u003cb\u003eFoot infection\u003c/b\u003e:\u003c/p\u003e \u003cp\u003eMild\u003c/p\u003e \u003cp\u003eModerate\u003c/p\u003e \u003cp\u003e\u003cb\u003eClinical stage\u003c/b\u003e:\u003c/p\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17 (56.7%)\u003c/p\u003e \u003cp\u003e13 (43.3%)\u003c/p\u003e \u003cp\u003e1 (3.3%)\u003c/p\u003e \u003cp\u003e17 (56.7%)\u003c/p\u003e \u003cp\u003e12 (40%)\u003c/p\u003e \u003cp\u003e16 (53.3%)\u003c/p\u003e \u003cp\u003e14 (46.7%)\u003c/p\u003e \u003cp\u003e30 (100%)\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\u003eBMI: Body mass index, IHD: Ischemic heart disease, HF: Heart failure, CVD: Cerebrovascular disease.\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\u003eClinical characteristics of patients at inclusion based on outcome.\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=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" 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\u003eHealed without major amputation (14)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eHealed with major amputation or unhealed and died (16)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariables\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eP value*\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=\"left\" colname=\"c2\"\u003e \u003cp\u003e57.57 (7.73)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e59.81 (8.76)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.467\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI (kg/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26.45 (2.48)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e27.26 (2.13)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.344\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDiabetes duration (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14.07 (3.56)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16.26 (4.97)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.184\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHbA1c (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7.87 (0.75)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8.06 (0.77)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.487\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eVariables\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003en (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003en (%)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003eP value^\u003c/b\u003e\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=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (64.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.299\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIHD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (42.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (31.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.707\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCHF\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (14.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCVD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (21.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (18.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDiabetes medications\u003c/b\u003e:\u003c/p\u003e \u003cp\u003eOnly Insulin\u003c/p\u003e \u003cp\u003eOral Hypoglycemic Medications\u0026thinsp;+\u0026thinsp;insulin\u003c/p\u003e \u003cp\u003eOnly oral Hypoglycemic Medications\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (50%)\u003c/p\u003e \u003cp\u003e5 (35.7%)\u003c/p\u003e \u003cp\u003e2 (14.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (50%)\u003c/p\u003e \u003cp\u003e2 (12.5%)\u003c/p\u003e \u003cp\u003e6 (37.5%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.220\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWound Wagner grade\u003c/b\u003e:\u003c/p\u003e \u003cp\u003e4\u003c/p\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (57.1%)\u003c/p\u003e \u003cp\u003e6 (42.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (56.3%)\u003c/p\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWIFI classification\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003eWound\u003c/b\u003e:\u003c/p\u003e \u003cp\u003eModerate\u003c/p\u003e \u003cp\u003eSevere\u003c/p\u003e \u003cp\u003e\u003cb\u003eIschemia\u003c/b\u003e:\u003c/p\u003e \u003cp\u003eMild\u003c/p\u003e \u003cp\u003eModerate\u003c/p\u003e \u003cp\u003eSevere\u003c/p\u003e \u003cp\u003e\u003cb\u003eFoot infection\u003c/b\u003e:\u003c/p\u003e \u003cp\u003eMild\u003c/p\u003e \u003cp\u003eModerate\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (57.1%)\u003c/p\u003e \u003cp\u003e6 (42.9%)\u003c/p\u003e \u003cp\u003e0 (0%)\u003c/p\u003e \u003cp\u003e9 (64.3%)\u003c/p\u003e \u003cp\u003e5 (35.7%)\u003c/p\u003e \u003cp\u003e9 (64.3%)\u003c/p\u003e \u003cp\u003e5 (35.7%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (56.3%)\u003c/p\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003cp\u003e8 (50%)\u003c/p\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003cp\u003e7 (43.8%)\u003c/p\u003e \u003cp\u003e9 (56.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003cp\u003e0.846\u003c/p\u003e \u003cp\u003e0.299\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\u003e*: Independent-T test, ^: Fisher\u0026rsquo;s exact test. BMI: Body mass index, IHD: Ischemic heart disease, HF: Heart failure, CVD: Cerebrovascular disease.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003ePatients with diabetes often have a vascular disease associated with atherosclerotic multilevel conditions affecting multiple arterial segments and organs and necessitating careful evaluation of all associated complications. Therefore, dialectologists, internists, and surgeons should collaborate aggressively to coordinate revascularization procedures, treat infections, and manage medical comorbidities associated with DFU, as it is a significant disease requiring multidisciplinary consensus. The risk of PAD and subsequent amputation is five to ten times higher in patients with diabetes than in those without diabetes, and the risk increases by 26% for every 1% increase in hemoglobin A1c level, as reported in several reviews (\u003cspan additionalcitationids=\"CR24 CR25\" citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). This study aimed to determine how early revascularization in patients with severe DFU and PAD affected their clinical outcomes. However, there is a severe lack of information regarding the effect of revascularization wait times on the outcomes of diabetic foot ulcers, particularly in patients with severe DFU. According to this study's findings, there was no significant difference between the variables based on the outcome (healed without major amputation, healed with major amputation, unhealed, or died). There was a significant correlation between a shorter time to revascularization (nine weeks or less) and a higher probability of healing without major amputation. The study of Elgzyri et al. (\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) showed that the time to vascular intervention within eight weeks, maximum Wagner grade reached\u0026thinsp;\u0026lt;\u0026thinsp;3, absence of peripheral edema, and presence of intermittent claudication were related to a higher probability of healing that is in line with present study findings. Together, this finding and the one that time to revascularization affects outcome suggest that patients with diabetes and ischemic foot ulcer, despite the presence of pain or the extent of wound and tissue destruction, should be considered for invasive revascularization as soon as possible. On the other hand, according to the findings of the present study, in patients with severe DFU (Wegener's wound grade 4 and 5) and ischemia, the earlier vascular intervention was associated with wound healing without the need for major amputation, which shows the importance of time in the treatment of this group of patients.\u003c/p\u003e \u003cp\u003eThe most important point of strength of the present study was to investigate the effect of vascular intervention time in patients with severe DFU and ischemia. The most important limitation of the present study can be the limitation in the sample size due to conducting the study in a single center to identify other factors affecting wound healing in patients. In this context, an attempt was made to investigate the effect of vascular intervention time on wound healing in a specific group of patients with severe DFU.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe results of the present study showed that shorter waiting time for vascular intervention in patients with severe DFU and ischemia is related to wound healing in patients without the need for major amputation. It is necessary to conduct more studies on the relationship between the time of vascular intervention in this group of patients.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that no funds, grants, or other support were received during the preparation of this manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interest:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have no relevant financial or non-financial interests to disclose.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Approval:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee\u0026nbsp;of the University of Medical Sciences.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInformed consent:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInformed consent was obtained from all individual participants included in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contribution:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDr. Arash Mohammadi Tofigh, participated in Supervision and validation.\u003c/p\u003e\n\u003cp\u003eDr. Majid Samsami, participated in Conceptualization and analysis.\u003c/p\u003e\n\u003cp\u003eDr. Alireza Haghbin Toutounchi, participated in Methodology and Writing - Review \u0026amp; Editing.\u003c/p\u003e\n\u003cp\u003eDr. Seyed Pedram Kouchak Hosseini, participated in Writing- Original draft and Visualization.\u003c/p\u003e\n\u003cp\u003eDr. Hojatolah Khoshnoudi, participated in Term and Data curation.\u003c/p\u003e\n\u003cp\u003eDr. Soheil Bagherian Lemraski: Project administration, corresponding author.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eRong F, Dai H, Wu Y, Li J, Liu G, Chen H, et al. Association between thyroid dysfunction and type 2 diabetes: a meta-analysis of prospective observational studies. BMC Med. 2021;19(1):257.\u003c/li\u003e\n\u003cli\u003eNasim K, Saeed B, Maryam E, Shiva B. Evaluation of Thyroid Function in Patients with Type II Diabetes during 2019-2021. Evaluation. 2022;10(3):2423-5571.\u003c/li\u003e\n\u003cli\u003eShaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010;87(1):4-14.\u003c/li\u003e\n\u003cli\u003eWhiting DR, Guariguata L, Weil C, Shaw J. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract. 2011;94(3):311-21.\u003c/li\u003e\n\u003cli\u003eGuariguata L. By the numbers: new estimates from the IDF Diabetes Atlas Update for 2012. Diabetes Res Clin Pract. 2012;98(3):524-5.\u003c/li\u003e\n\u003cli\u003eTudor RM, Garrahy A, Woods CP, Crowley RK, Tormey WT, Smith D, et al. The prevalence and incidence of thyroid dysfunction in patients with diabetes - a longitudinal follow-up study. Ir J Med Sci. 2020;189(1):171-5.\u003c/li\u003e\n\u003cli\u003eShi L, Shu XO, Li H, Cai H, Liu Q, Zheng W, et al. Physical activity, smoking, and alcohol consumption in association with incidence of type 2 diabetes among middle-aged and elderly Chinese men. PLoS One. 2013;8(11):e77919.\u003c/li\u003e\n\u003cli\u003eOgbonna SU, Ezeani IU. Risk Factors of Thyroid Dysfunction in Patients With Type 2 Diabetes Mellitus. Front Endocrinol (Lausanne). 2019;10:440.\u003c/li\u003e\n\u003cli\u003eAliabadi DA, Moradian N, Rahmanian E, Mohammadi M. Prevalence of neuropathy in patients with type 2 diabetes in Iran : A systematic review and meta-analysis. Wien Klin Wochenschr. 2021;133(5-6):222-8.\u003c/li\u003e\n\u003cli\u003eYekta Z, Pourali R, Ghasemi-Rad M. Comparison of demographic and clinical characteristics influencing health-related quality of life in patients with diabetic foot ulcers and those without foot ulcers. Diabetes Metab Syndr Obes. 2011;4:393-9.\u003c/li\u003e\n\u003cli\u003eTabatabaei Malazy O, Mohajeri-Tehrani MR, Pajouhi M, Shojaei Fard A, Amini MR, Larijani B. Iranian Diabetic Foot Research Network. Adv Skin Wound Care. 2010;23(10):450-4.\u003c/li\u003e\n\u003cli\u003eAalaa M, Malazy OT, Sanjari M, Peimani M, Mohajeri-Tehrani M. Nurses\u0026apos; role in diabetic foot prevention and care; a review. J Diabetes Metab Disord. 2012;11(1):24.\u003c/li\u003e\n\u003cli\u003eAlikhani A, Moradi M, Alikhani S. Epidemiological study, risk factors and clinical outcomes of diabetic foot infection in hospitalized patients. Journal of Mazandaran University of Medical Sciences. 2015;25(129):81-91.\u003c/li\u003e\n\u003cli\u003eLipsky BA, Berendt AR, Deery HG, Embil JM, Joseph WS, Karchmer AW, et al. Diagnosis and treatment of diabetic foot infections. Clinical infectious diseases. 2004;39(7):885-910.\u003c/li\u003e\n\u003cli\u003eHoulind K. Surgical revascularization and reconstruction procedures in diabetic foot ulceration. Diabetes/Metabolism Research and Reviews. 2020;36(s1):e3256.\u003c/li\u003e\n\u003cli\u003eWendling S, Beadle V. The relationship between self-efficacy and diabetic foot self-care. J Clin Transl Endocrinol. 2015;2(1):37-41.\u003c/li\u003e\n\u003cli\u003eSchaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev. 2020;36 Suppl 1:e3266.\u003c/li\u003e\n\u003cli\u003eOdink H, van den Berg A, Winkens B. Technical and clinical long-term results of infrapopliteal percutaneous transluminal angioplasty for critical limb ischemia. J Vasc Interv Radiol. 2012;23(4):461-7, 7.e1.\u003c/li\u003e\n\u003cli\u003ePeregrin JH, Koznar B, Kov\u0026aacute;c J, Lastovickov\u0026aacute; J, Novotn\u0026yacute; J, Vedlich D, et al. PTA of infrapopliteal arteries: long-term clinical follow-up and analysis of factors influencing clinical outcome. Cardiovasc Intervent Radiol. 2010;33(4):720-5.\u003c/li\u003e\n\u003cli\u003eHinchliffe RJ, Forsythe RO, Apelqvist J, Boyko EJ, Fitridge R, Hong JP, et al. Guidelines on diagnosis, prognosis, and management of peripheral artery disease in patients with foot ulcers and diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020;36 Suppl 1:e3276.\u003c/li\u003e\n\u003cli\u003eElgzyri T, Larsson J, Nyberg P, Th\u0026ouml;rne J, Eriksson KF, Apelqvist J. Early Revascularization after Admittance to a Diabetic Foot Center Affects the Healing Probability of Ischemic Foot Ulcer in Patients with Diabetes. European Journal of Vascular and Endovascular Surgery. 2014;48(4):440-6.\u003c/li\u003e\n\u003cli\u003eApelqvist J, Lep\u0026auml;ntalo M. The ulcerated leg: when to revascularize. Diabetes/metabolism research and reviews. 2012;28:30-5.\u003c/li\u003e\n\u003cli\u003eDinoto E, Ferlito F, La Marca MA, Tortomasi G, Urso F, Evola S, et al. The Role of Early Revascularization and Biomarkers in the Management of Diabetic Foot Ulcers: A Single Center Experience. Diagnostics (Basel). 2022;12(2).\u003c/li\u003e\n\u003cli\u003eOlinic DM, Spinu M, Olinic M, Homorodean C, Tataru DA, Liew A, et al. Epidemiology of peripheral artery disease in Europe: VAS Educational Paper. Int Angiol. 2018;37(4):327-34.\u003c/li\u003e\n\u003cli\u003eLep\u0026auml;ntalo M, Apelqvist J, Setacci C, Ricco JB, de Donato G, Becker F, et al. Chapter V: Diabetic foot. Eur J Vasc Endovasc Surg. 2011;42 Suppl 2:S60-74.\u003c/li\u003e\n\u003cli\u003eBracale UM, Ammollo RP, Hussein EA, Hoballah JJ, Goeau-Brissonniere O, Taurino M, et al. Managing Peripheral Artery Disease in Diabetic Patients: A Questionnaire Survey from Vascular Centers of the Mediterranean Federation for the Advancing of Vascular Surgery (MeFAVS). Ann Vasc Surg. 2020;64:239-45.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Shahid Beheshti University of Medical Sciences","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":"Early revascularization, Diabetic foot ulcer, Angioplasty, Ischemia, peripheral artery disease","lastPublishedDoi":"10.21203/rs.3.rs-5060078/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5060078/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective:\u003c/strong\u003e The effect of early revascularization on preventing amputation of diabetic foot ulcers (DFU) patients is challenging. This study aimed to evaluate the impact of early revascularization in ischemic severe DFU outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e This prospective cohort study was conducted on 30 patients with severe DFU (Wound Wagner grade 4 and 5), and peripheral artery disease referred to Imam Hossein Hospital in Tehran, Iran, from April 2020 to March 2022. All patients underwent lower limb vascular surgery. Patients were examined for 20 months regarding wound healing, amputation, and death. Data were analyzed by SPSS statistic version 27.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e The present study included 30 patients (30 lower limbs). The mean time of patients’ follow-up to outcome was 12.56 (SD=4.36, 3-20) months. The mean wait time to revascularization was 8.90 (SD= 2.32, 6-15) weeks. Nine patients (30%) waited more than nine weeks for revascularization. Totally 14 patients (46.7%) healed without major amputation. A shorter time to revascularization (9 weeks and less) was significantly related to a higher probability of healing without major amputation over time (P value= 0.017).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e The results of the present study showed that shorter waiting time for vascular intervention in patients with severe DFU and ischemia is related to wound healing in patients without the need for major amputation. It seems necessary to conduct more studies about the time of vascular intervention in this group of patients.\u003c/p\u003e","manuscriptTitle":"Clinical outcomes of early revascularization in severe diabetic foot ulcer with ischemia: a single center experience","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-09-11 08:41:19","doi":"10.21203/rs.3.rs-5060078/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":"4636d4c2-1d74-46ed-a7ce-5166b377b17c","owner":[],"postedDate":"September 11th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":37347463,"name":"General Surgery"},{"id":37347464,"name":"Vascular Medicine"},{"id":37347465,"name":"Cardiac \u0026 Cardiovascular Systems"},{"id":37347466,"name":"Endocrinology \u0026 Metabolism"}],"tags":[],"updatedAt":"2024-09-11T08:41:19+00:00","versionOfRecord":[],"versionCreatedAt":"2024-09-11 08:41:19","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5060078","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5060078","identity":"rs-5060078","version":["v1"]},"buildId":"cBFmMYwuxLRRLfASyISRj","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}