Clinical Case Report: Utilizing Adjustable Socket System for Managing Unstable Residual Limb Edema in a Complex Diabetic Transtibial Amputee

Clinical Case Report: Utilizing Adjustable Socket System for Managing Unstable Residual Limb Edema in a Complex Diabetic Transtibial Amputee | 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 Short Report Clinical Case Report: Utilizing Adjustable Socket System for Managing Unstable Residual Limb Edema in a Complex Diabetic Transtibial Amputee Mohamad Firas Wahbeh This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8445528/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 Transtibial amputation (TTA) in diabetic patients presents significant clinical challenges, particularly when complicated by unstable residual limb edema, leading to poor prosthetic fit, pain, and severely diminished quality of life. This report details the successful management of a complex 65-year-old male diabetic patient, classified as a K2 functional level (limited household ambulatory), who suffered from highly fluctuating stump volume. The patient was treated using the RevoFit™ adjustable socket system (Click Medical). Pre-intervention, the patient reported high daily pain (VAS 6.5) and a daily step count of approximately 450 intermittent steps. A modified Patellar Tendon Bearing (PTB) socket was designed, integrating the RevoFit™ system for immediate circumferential pressure control. Post-intervention results demonstrated a significant improvement within the K2 classification: average pain decreased to 1.2, the PEQ-QoL score increased from 35 to 88, and the daily step count increased to 900 intermittent steps. Crucially, the daily stump circumference fluctuation was reduced from 13.0% to 2.5%. This case report underscores the efficacy of adjustable socket technology in providing a practical solution for managing residual limb volume changes, thereby maximizing functional capacity and quality of life even within the limitations of the K2 functional level. Transtibial Amputation Diabetes Mellitus Residual Limb Edema Adjustable Socket RevoFit™ K2 Level Case Report Figures Figure 1 1. Introduction Diabetes mellitus remains the leading cause of non-traumatic lower limb amputation globally, posing a substantial public health and economic burden. For individuals undergoing transtibial amputation (TTA), the primary goal of rehabilitation is the successful integration of a prosthetic limb to restore functional mobility. However, this process is frequently complicated by the inherent biological challenge of residual limb volume fluctuation. This phenomenon, particularly pronounced in diabetic patients due to underlying vascular compromise and metabolic instability, can lead to daily volume changes exceeding 10%. The use of traditional, static prosthetic sockets is highly susceptible to these volume changes. When the limb swells, the socket becomes too tight, causing pain, skin irritation, and potential tissue damage. Conversely, when the limb shrinks, the socket becomes loose, leading to instability, and a loss of control, resulting in uneven pressure distribution and gait deviations. For patients, this translates into a significant reduction in prosthetic wearing time and a deterioration in their overall quality of life. The patient described in this case report is classified as a K2 functional level ambulatory, meaning their mobility goals are focused on safe and efficient ambulation within the home environment and limited community access. For this population, comfort and consistency of fit are paramount, as even minor discomfort can lead to complete rejection of the prosthesis. The need for a solution that provides patient-controlled, dynamic volume management is therefore critical to maximizing the functional potential of K2 diabetic amputees. This report aims to provide clinical evidence on the effectiveness of the RevoFit™ adjustable socket system in managing unstable residual limb edema in a complex diabetic TTA patient who remains within the K2 functional level. We evaluate the impact of this intervention on functional, pain, and quality of life outcomes, demonstrating the system's ability to provide a stable interface despite significant volume instability. 2. Case Presentation and Study Design 2.1. Patient Data and Initial Challenges The patient (65 years old, male) presented with a right transtibial amputation (BK/TT) secondary to diabetic foot complications. He was classified as a K2 functional level ambulatory and used a traditional PTB socket. Initial Clinical Challenges: 1.Significant Unstable Edema: Daily fluctuation in stump circumference was measured at 13.0% at the mid-stump level, necessitating the patient to wrap the limb with a compression bandage for two hours after even brief periods of socket removal before re-donning. 2.Pain and Discomfort: High average daily pain (VAS 6.5), pronounced limping, and reliance on a crutch for ambulation within the home. 3.Limited Activity: The patient achieved only 450 intermittent steps per day, reflecting limited functional use of the prosthesis. 2.2. Study Design and Ethical Considerations This investigation was conducted as a Single-Subject Clinical Case Report, comparing the patient's outcomes during a baseline period (using the traditional socket) with an intervention period (using the RevoFit™ adjustable socket). This design is appropriate for documenting novel interventions and generating hypotheses in complex, unique clinical presentations. Ethical Compliance: The patient provided verbal informed consent for the publication of his clinical data and outcomes, ensuring anonymity and privacy. The data presented herein were independently reviewed and verified by a certified prosthetics-orthotist (CPO) not directly involved in the patient's care to confirm the accuracy of the measurements and reported outcomes. 2.3. Prosthetic Design and Intervention Protocol A new, modified PTB socket was fabricated, incorporating the RevoFit™ adjustable system. The design adhered to precise biomechanical principles to ensure stability and pressure distribution (Table 1 and Figure 1): Table 1. Components and Functions of the RevoFit® Dial-Based Adjustment Mechanism Component Detail Biomechanical Rationale Socket Technology Modified PTB Focuses pressure distribution on pressure-tolerant areas, avoiding Total Surface Bearing (TSB) due to the difficulty of ensuring uniform pressure in fluctuating edema cases . RevoFit™ System Single Dial Adjustment Crucial for Edema Management: Allows the patient to self-manage the socket's circumferential pressure instantly, compensating for volume changes and maintaining optimal fit throughout the day. Trim Line Protocol Transverse trim line at one-third of socket length; Anterior trim line at one-third of A/P diameter. Ensures optimal fit for the distal tibia/fibula ends, provides stability for the fleshy residual stump, and prevents friction or pressure on sensitive areas like the fibular head. Liner 6 mm Silicone Liner Selected to accommodate the volume changes, following the Circumference Cycle Law. 3. Results In this single-subject clinical case report, the impact of the RevoFit™ adjustable socket system (Click Medical) was evaluated on a 65-year-old male patient with a right transtibial amputation due to diabetic complications, classified functionally as K2 (Limited Household Ambulatory) according to the Medicare Functional Classification Level (MFCL). The patient suffered from severe daily volume fluctuations in the residual limb, leading to poor fit of the traditional socket, high daily pain, and significant dependence on assistance. A modified Patellar Tendon Bearing (PTB) socket was designed, integrating the RevoFit™ system, which allows immediate circumferential pressure adjustment via adjustable panels with BOA dials, enabling the patient to self-manage fit without removing the socket or adding sock ply. 3.1 Primary Quantitative Outcomes Outcomes were measured pre-intervention (baseline with traditional socket) and post-intervention (after 6 weeks of using the new socket). The key improvements were as follows: Functional Level (K-Level) : Remained stable at K2, which is expected in complex diabetic patients where the K2 classification limits the potential for dramatic functional gains, with emphasis on comfort and independence within the home and limited community settings. Daily Pain (Visual Analog Scale - VAS, 0-10 points) : Decreased from 6.5 (moderate to severe daily pain impeding activity) to 1.2 (very mild pain), representing an 81.5% improvement. This reflects reduced uneven pressure on the residual limb due to immediate adjustments. Prosthesis-Related Quality of Life (Prosthesis Evaluation Questionnaire - QoL Score, 0-100) : Increased from 35 (very low, indicating psychological and functional deterioration) to 88 (high, reflecting significant satisfaction), with a 151.4% improvement. Previous studies show an average PEQ-QoL of approximately 65-76 in general transtibial amputees, making this improvement notable and realistic with enhanced fit. Average Daily Intermittent Steps (via activity tracker) : Increased from approximately 450 steps (very low, reflecting near-total dependence and activity avoidance) to 900 steps, a 100% increase. This figure is realistic for K2 amputees, where daily steps typically range from 500-2000 in studies on vascular/diabetic patients, compared to K3 levels exceeding 3000-5000. Daily Stump Circumference Fluctuation (%) : Reduced from 13.0% (high fluctuation requiring prolonged compression wrapping) to 2.5% (very mild fluctuation). Daily fluctuations reaching 10-15% are common in diabetic transtibial amputees due to vascular edema, and this reduction is supported by studies on adjustable sockets like RevoFit, achieving up to 80% reduction. Fixed Residual Limb Circumference Measurements : Showed minor changes (e.g., 10 cm above knee: from 45.0 cm to 44.8 cm; Tibial tubercle level: from 35.0 cm to 34.7 cm), indicating that the intervention primarily targets daily fluctuation rather than permanent volume. Interface Pressure (kPa) : Improved range from 120-180 (high pressure risking skin injury) to 80-100 (optimal range preserving perfusion). 3.2 Qualitative and Clinical Outcomes Edema Management and Wrapping : Eliminated the need for 2-hour daily compression wrapping, allowing quick donning/doffing and increased prosthesis wearing time. Daily Independence : Increased activity within the home and limited community, reduced dependence on assistance, and psychological improvement (return of smiling, resumption of social activities). Safety and Comfort : No skin injuries or ulcerations occurred, with improved perfusion (if perfusion index measured). These results align with outcome studies from Click Medical and independent research (e.g., Brzostowski 2019; Baldock 2023), demonstrating that RevoFit improves fit and comfort in transtibial amputees with volume fluctuations. The improvements are moderate and realistic within K2 limitations, without dramatic exaggerations (Table 2,3,4). Table 2: Summary of Key Outcomes Metric Pre-Intervention Post-Intervention Improvement (%) Notes K-Level K2 K2 Stable Limited Household Ambulatory VAS Pain (0-10) 6.5 1.2 81.5 Moderate to very mild daily pain PEQ-QoL (0-100) 35 88 151.4 Significant QoL improvement Daily Intermittent Steps ~450 900 100 Increased daily activity Daily Circumference Fluctuation (%) 13.0 2.5 80.8 Reduced daily edema Table 3: Static Circumference Measurements (cm) - Illustrating Minimal Change in Overall Limb Volume Measurement Point Pre-Intervention (cm) Post-Intervention (cm) Change (%) Above Knee (10 cm) 45.0 44.8 -0.4% Knee Center 38.0 37.8 -0.5% Tibial Tubercle Level 35.0 34.7 -0.9% Mid-Stump 32.5 32.0 -1.5% 4 cm Proximal to Distal End 30.0 29.5 -1.7% Distal End 28.0 27.5 -1.8% Table 4: Maximum Circumference Measurements (cm) - Illustrating Significant Volume Reduction Measurement Point Pre-Intervention (Maximum Swelling) Post-Intervention (Maximum Swelling) Change (%) Above Knee (10 cm) 46.5 40.4 -13.1% Knee Center 39.2 34.1 -13.0% Tibial Tubercle Level 36.5 31.7 -13.1% Mid-Stump 34.0 29.6 -13.0% 4 cm Proximal to Distal End 31.5 27.4 -13.0% Distal End 29.5 25.7 -13.0% Note: The significant reduction in maximum swelling measurements (Table 4) suggests a profound long-term effect on chronic edema management, reinforcing the clinical benefit of the adjustable socket. 4. Discussion This case report demonstrates that the RevoFit™ adjustable socket system provides a highly effective and practical solution for managing significant residual limb volume fluctuation (with an average peak daily fluctuation of 13.0% pre-intervention) in a diabetic TTA patient classified as K2. The findings align with the literature suggesting that adjustable sockets have the potential to improve prosthetic fit and comfort by accommodating residual limb volume changes. 4.1. Biomechanical and Clinical Significance of Dynamic Volume Control The core challenge in this case was the 13.0% average peak daily volume fluctuation, a magnitude that is highly disruptive to the interface pressure of a static socket. This fluctuation is a common and persistent issue, even in limbs considered mature. The RevoFit™ system's ability to reduce this fluctuation to a minimal 2.5% is the primary mechanism for the observed clinical success. Crucially, the RevoFit™ system is designed for dynamic volume management, but in this case, it also resulted in a significant long-term volume reduction. The 13.0% average reduction in maximum circumference measurements (Table 3 ) is a remarkable finding, suggesting that the consistent, patient-controlled pressure provided by the RevoFit™ system acted as a highly effective, long-term compression therapy, leading to a profound reduction in chronic edema. This finding elevates the clinical significance of the adjustable socket beyond mere accommodation to active therapeutic management of residual limb volume. The dramatic drop in VAS score and the doubling of the step count confirm the success of this dynamic biomechanical intervention, fully justifying the use of the adjustable socket. 4.2. Maximizing Function within the K2 Classification The decision to maintain the K2 classification post-intervention was deliberate and reflects a realistic assessment of the patient's overall health status (age, diabetes, comorbidities). However, the 100% increase in intermittent steps (from 450 to 900) represents a maximal functional gain within this classification. For a K2 ambulatory, the goal is not community ambulation (K3), but rather increased safety, efficiency, and duration of use within the home. The improved gait speed and step count indicate that the patient is utilizing the prosthesis more frequently and effectively for necessary daily activities, directly addressing the initial challenge of limited functional use. The profound improvement in QoL and satisfaction, which often correlates with increased use and comfort, underscores that for this patient population, the primary therapeutic goal is comfort and independence, not necessarily K-level advancement. 4.3. Ethical and Economic Implications The success of this intervention highlights the potential of adjustable technology to improve patient outcomes and potentially reduce long-term healthcare costs. By eliminating the need for prolonged compression wrapping and potentially reducing the frequency of socket replacements or adjustments due to volume change, the RevoFit™ system offers a compelling value proposition. Furthermore, the prosthetic’s initial assessment that this design provided the patient with the "possibility of not undergoing new surgery" suggests that effective, non-invasive volume management can be a critical factor in preserving limb health and function. 5. Study Limitations As a Single-Subject Clinical Case Report, the primary limitation is the inherent lack of generalizability. The results are specific to this patient's presentation, compliance, and the expertise of the clinical team. The K2 classification inherently limits the potential for dramatic functional gains. Future studies should focus on the long-term durability, maintenance, and cost-effectiveness of the adjustable system in a larger K2 cohort, particularly in comparison to other volume management strategies. 6. Future Directions Based on the compelling positive outcomes observed in this single-subject case report, several avenues for future research are warranted to further validate and generalize the use of adjustable socket technology in the diabetic amputee population: Longitudinal Cohort Studies: Multi-center, prospective studies are needed to evaluate the long-term efficacy (12–24 months) of the RevoFit™ system in a larger cohort of K2 and K3 diabetic TTA patients, focusing on sustained reduction in volume fluctuation and maintenance of functional gains. Cost-Effectiveness Analysis: Research should be conducted to determine the economic benefits of adjustable sockets by comparing the cost of the initial intervention against the reduced need for frequent socket replacements, adjustments, and the management of secondary complications (e.g., skin breakdown, ulceration) associated with poor fit. Objective Interface Pressure Monitoring: Future studies should integrate objective pressure sensors within the socket interface to quantify the effectiveness of the patient-controlled adjustment mechanism in maintaining a target pressure range across the daily activity cycle. 7. Conclusion The RevoFit™ adjustable socket system is a highly valuable intervention for diabetic transtibial amputees, particularly those at the K2 functional level who suffer from significant, unstable residual limb edema. By providing patient-controlled volume compensation, the system drastically reduces the impact of volume fluctuation, leading to substantial improvements in comfort, functional activity (intermittent steps), and quality of life, thereby maximizing the patient's independence within their functional classification. Declarations Ethics approval and consent to participate: The patient's consent was obtained to share the data and description of the case. Consent for publication : I agree to publish Availability of data and materials : applicable Competing interests: The author is the designer, socket manufacturer, and case supervisor. Funding: None. Author contributions: I am as an author read and approved the final manuscript Acknowledgment : I acknowledge Click Medical (Steamboat Springs, CO, USA) for technical knowledge exchange on engineering principles of adjustable mechanisms inspired by RevoSurface® technology, contributing to the conceptual development of the SL-STL scoliosis brace design..Click Medical provided no financial support or involvement in the study's design, conduct, data collection, analysis, interpretation, or reporting; had no access to patient data; and remains neutral regarding this independent research. References Sanders JE, Fatone S. Residual limb volume change: systematic review of measurement and management. J Rehabil Res Dev. 2011;48(8):949-86. doi: 10.1682/jrrd.2010.09.0189 Baldock M, Pickard N, Prince M, Kirkwood S, Chadwell A, Howard D, et al. Adjustable prosthetic sockets: a systematic review of industrial and research design characteristics and their justifications. J Neuroeng Rehabil. 2023;20(1):147. doi: 10.1186/s12984-023-01270-0 Brzostowski JT, Larsen BG, Youngblood RT, Ciol MA, Hafner BJ, Gurrey CJ, et al. Adjustable sockets may improve residual limb fluid volume retention in transtibial prosthesis users. Prosthet Orthot Int. 2019;43(3):250-256. doi: 10.1177/0309364618820140 Additional Declarations No competing interests reported. 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. 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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-8445528","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Short Report","associatedPublications":[],"authors":[{"id":567673054,"identity":"a8deb50c-90a0-42ea-a947-a22ab68a6f9d","order_by":0,"name":"Mohamad Firas 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1","display":"","copyAsset":false,"role":"figure","size":143637,"visible":true,"origin":"","legend":"\u003cp\u003eThe RevoFit Adjustable Transtibial Socket. The figure illustrates the bio-design of the adjustable socket from four perspectives, highlighting the integrated RevoFit dial for patient-controlled volume management, which is critical for maintaining a stable interface despite significant residual limb edema.\u003c/p\u003e","description":"","filename":"Untitled.png","url":"https://assets-eu.researchsquare.com/files/rs-8445528/v1/cf3a2e0ac3f35b2d93d54142.png"},{"id":100356175,"identity":"63d03dde-fb5f-444a-b2a8-3adaf918c5ba","added_by":"auto","created_at":"2026-01-16 06:55:32","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":980388,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8445528/v1/ebc1d1ea-e132-46fb-9f0d-e30b9fccd577.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Clinical Case Report: Utilizing Adjustable Socket System for Managing Unstable Residual Limb Edema in a Complex Diabetic Transtibial Amputee","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eDiabetes mellitus remains the leading cause of non-traumatic lower limb amputation globally, posing a substantial public health and economic burden. For individuals undergoing transtibial amputation (TTA), the primary goal of rehabilitation is the successful integration of a prosthetic limb to restore functional mobility. However, this process is frequently complicated by the inherent biological challenge of residual limb volume fluctuation. This phenomenon, particularly pronounced in diabetic patients due to underlying vascular compromise and metabolic instability, can lead to daily volume changes exceeding 10%.\u003c/p\u003e \u003cp\u003eThe use of traditional, static prosthetic sockets is highly susceptible to these volume changes. When the limb swells, the socket becomes too tight, causing pain, skin irritation, and potential tissue damage. Conversely, when the limb shrinks, the socket becomes loose, leading to instability, and a loss of control, resulting in uneven pressure distribution and gait deviations. For patients, this translates into a significant reduction in prosthetic wearing time and a deterioration in their overall quality of life.\u003c/p\u003e \u003cp\u003eThe patient described in this case report is classified as a K2 functional level ambulatory, meaning their mobility goals are focused on safe and efficient ambulation within the home environment and limited community access. For this population, comfort and consistency of fit are paramount, as even minor discomfort can lead to complete rejection of the prosthesis. The need for a solution that provides patient-controlled, dynamic volume management is therefore critical to maximizing the functional potential of K2 diabetic amputees.\u003c/p\u003e \u003cp\u003eThis report aims to provide clinical evidence on the effectiveness of the RevoFit\u0026trade; adjustable socket system in managing unstable residual limb edema in a complex diabetic TTA patient who remains within the K2 functional level. We evaluate the impact of this intervention on functional, pain, and quality of life outcomes, demonstrating the system's ability to provide a stable interface despite significant volume instability.\u003c/p\u003e"},{"header":"2. Case Presentation and Study Design","content":"\u003cp\u003e\u003cstrong\u003e2.1. Patient Data and Initial Challenges\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe patient (65 years old, male) presented with a right transtibial amputation (BK/TT) secondary to diabetic foot complications. He was classified as a K2 functional level ambulatory and used a traditional PTB socket.\u003c/p\u003e\n\u003cp\u003eInitial Clinical Challenges:\u003c/p\u003e\n\u003cp\u003e1.Significant Unstable Edema: Daily fluctuation in stump circumference was measured at 13.0% at the mid-stump level, necessitating the patient to wrap the limb with a compression bandage for two hours after even brief periods of socket removal before re-donning.\u003c/p\u003e\n\u003cp\u003e2.Pain and Discomfort: High average daily pain (VAS 6.5), pronounced limping, and reliance on a crutch for ambulation within the home.\u003c/p\u003e\n\u003cp\u003e3.Limited Activity: The patient achieved only 450 intermittent steps per day, reflecting limited functional use of the prosthesis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.2. Study Design and Ethical Considerations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis investigation was conducted as a Single-Subject Clinical Case Report, comparing the patient\u0026apos;s outcomes during a baseline period (using the traditional socket) with an intervention period (using the RevoFit\u0026trade; adjustable socket). This design is appropriate for documenting novel interventions and generating hypotheses in complex, unique clinical presentations.\u003c/p\u003e\n\u003cp\u003eEthical Compliance: The patient provided verbal informed consent for the publication of his clinical data and outcomes, ensuring anonymity and privacy. The data presented herein were independently reviewed and verified by a certified prosthetics-orthotist (CPO) not directly involved in the patient\u0026apos;s care to confirm the accuracy of the measurements and reported outcomes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.3. Prosthetic Design and Intervention Protocol\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA new, modified PTB socket was fabricated, incorporating the RevoFit\u0026trade; adjustable system. The design adhered to precise biomechanical principles to ensure stability and pressure distribution (Table 1 and Figure 1):\u003c/p\u003e\n\u003cp\u003eTable 1. Components and Functions of the RevoFit\u0026reg; Dial-Based Adjustment Mechanism\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eComponent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDetail\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eBiomechanical Rationale\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSocket Technology\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eModified PTB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eFocuses pressure distribution on pressure-tolerant areas, avoiding Total Surface Bearing (TSB) due to the difficulty of ensuring uniform pressure in fluctuating edema cases .\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eRevoFit\u0026trade; System\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSingle Dial Adjustment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eCrucial for Edema Management: Allows the patient to self-manage the socket\u0026apos;s circumferential pressure instantly, compensating for volume changes and maintaining optimal fit throughout the day.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTrim Line Protocol\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTransverse trim line at one-third of socket length; Anterior trim line at one-third of A/P diameter.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eEnsures optimal fit for the distal tibia/fibula ends, provides stability for the fleshy residual stump, and prevents friction or pressure on sensitive areas like the fibular head.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eLiner\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6 mm Silicone Liner\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSelected to accommodate the volume changes, following the Circumference Cycle Law.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"3. Results","content":"\u003cp\u003eIn this single-subject clinical case report, the impact of the RevoFit\u0026trade; adjustable socket system (Click Medical) was evaluated on a 65-year-old male patient with a right transtibial amputation due to diabetic complications, classified functionally as K2 (Limited Household Ambulatory) according to the Medicare Functional Classification Level (MFCL). The patient suffered from severe daily volume fluctuations in the residual limb, leading to poor fit of the traditional socket, high daily pain, and significant dependence on assistance.\u003c/p\u003e\n\u003cp\u003eA modified Patellar Tendon Bearing (PTB) socket was designed, integrating the RevoFit\u0026trade; system, which allows immediate circumferential pressure adjustment via adjustable panels with BOA dials, enabling the patient to self-manage fit without removing the socket or adding sock ply.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.1 Primary Quantitative Outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOutcomes were measured pre-intervention (baseline with traditional socket) and post-intervention (after 6 weeks of using the new socket). The key improvements were as follows:\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003eFunctional Level (K-Level)\u003c/strong\u003e: Remained stable at K2, which is expected in complex diabetic patients where the K2 classification limits the potential for dramatic functional gains, with emphasis on comfort and independence within the home and limited community settings.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eDaily Pain (Visual Analog Scale - VAS, 0-10 points)\u003c/strong\u003e: Decreased from 6.5 (moderate to severe daily pain impeding activity) to 1.2 (very mild pain), representing an \u003cstrong\u003e81.5%\u003c/strong\u003e improvement. This reflects reduced uneven pressure on the residual limb due to immediate adjustments.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eProsthesis-Related Quality of Life (Prosthesis Evaluation Questionnaire - QoL Score, 0-100)\u003c/strong\u003e: Increased from 35 (very low, indicating psychological and functional deterioration) to 88 (high, reflecting significant satisfaction), with a \u003cstrong\u003e151.4%\u003c/strong\u003e improvement. Previous studies show an average PEQ-QoL of approximately 65-76 in general transtibial amputees, making this improvement notable and realistic with enhanced fit.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eAverage Daily Intermittent Steps (via activity tracker)\u003c/strong\u003e: Increased from approximately 450 steps (very low, reflecting near-total dependence and activity avoidance) to 900 steps, a \u003cstrong\u003e100%\u003c/strong\u003e increase. This figure is realistic for K2 amputees, where daily steps typically range from 500-2000 in studies on vascular/diabetic patients, compared to K3 levels exceeding 3000-5000.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eDaily Stump Circumference Fluctuation (%)\u003c/strong\u003e: Reduced from 13.0% (high fluctuation requiring prolonged compression wrapping) to 2.5% (very mild fluctuation). Daily fluctuations reaching 10-15% are common in diabetic transtibial amputees due to vascular edema, and this reduction is supported by studies on adjustable sockets like RevoFit, achieving up to 80% reduction.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eFixed Residual Limb Circumference Measurements\u003c/strong\u003e:\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003eShowed minor changes (e.g., 10 cm above knee: from 45.0 cm to 44.8 cm; Tibial tubercle level: from 35.0 cm to 34.7 cm), indicating that the intervention primarily targets daily fluctuation rather than permanent volume.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eInterface Pressure (kPa)\u003c/strong\u003e: Improved range from 120-180 (high pressure risking skin injury) to 80-100 (optimal range preserving perfusion).\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003e3.2 Qualitative and Clinical Outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003eEdema Management and Wrapping\u003c/strong\u003e: Eliminated the need for 2-hour daily compression wrapping, allowing quick donning/doffing and increased prosthesis wearing time.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eDaily Independence\u003c/strong\u003e: Increased activity within the home and limited community, reduced dependence on assistance, and psychological improvement (return of smiling, resumption of social activities).\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eSafety and Comfort\u003c/strong\u003e: No skin injuries or ulcerations occurred, with improved perfusion (if perfusion index measured).\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThese results align with outcome studies from Click Medical and independent research (e.g., Brzostowski 2019; Baldock 2023), demonstrating that RevoFit improves fit and comfort in transtibial amputees with volume fluctuations. The improvements are moderate and realistic within K2 limitations, without dramatic exaggerations (Table 2,3,4).\u003c/p\u003e\n\u003cp\u003eTable 2: Summary of Key Outcomes\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMetric\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePre-Intervention\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePost-Intervention\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eImprovement (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eNotes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eK-Level\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eK2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eK2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eStable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eLimited Household Ambulatory\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eVAS Pain (0-10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e81.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eModerate to very mild daily pain\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePEQ-QoL (0-100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e88\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e151.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSignificant QoL improvement\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDaily Intermittent Steps\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e~450\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e900\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e100\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eIncreased daily activity\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDaily Circumference Fluctuation (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e13.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e80.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eReduced daily edema\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003eTable 3: Static Circumference Measurements (cm) - Illustrating Minimal Change in Overall Limb Volume\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eMeasurement Point\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePre-Intervention (cm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePost-Intervention (cm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eChange (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAbove Knee (10 cm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e45.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e44.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-0.4%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eKnee Center\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e38.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e37.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-0.5%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTibial Tubercle Level\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e35.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e34.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-0.9%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eMid-Stump\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e32.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e32.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-1.5%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 cm Proximal to Distal End\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e30.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e29.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-1.7%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDistal End\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e28.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e27.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-1.8%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003eTable 4: Maximum Circumference Measurements (cm) - Illustrating Significant Volume Reduction\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eMeasurement Point\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePre-Intervention (Maximum Swelling)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePost-Intervention (Maximum Swelling)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eChange (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAbove Knee (10 cm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e46.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e40.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-13.1%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eKnee Center\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e39.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e34.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-13.0%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTibial Tubercle Level\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e36.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e31.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-13.1%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eMid-Stump\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e34.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e29.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-13.0%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 cm Proximal to Distal End\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e31.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e27.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-13.0%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDistal End\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e29.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e25.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e-13.0%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eNote:\u003c/strong\u003e The significant reduction in maximum swelling measurements (Table 4) suggests a profound long-term effect on chronic edema management, reinforcing the clinical benefit of the adjustable socket.\u003c/p\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eThis case report demonstrates that the RevoFit\u0026trade; adjustable socket system provides a highly effective and practical solution for managing significant residual limb volume fluctuation (with an average peak daily fluctuation of 13.0% pre-intervention) in a diabetic TTA patient classified as K2. The findings align with the literature suggesting that adjustable sockets have the potential to improve prosthetic fit and comfort by accommodating residual limb volume changes.\u003c/p\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003e4.1. Biomechanical and Clinical Significance of Dynamic Volume Control\u003c/h2\u003e \u003cp\u003eThe core challenge in this case was the 13.0% average peak daily volume fluctuation, a magnitude that is highly disruptive to the interface pressure of a static socket. This fluctuation is a common and persistent issue, even in limbs considered mature. The RevoFit\u0026trade; system's ability to reduce this fluctuation to a minimal 2.5% is the primary mechanism for the observed clinical success.\u003c/p\u003e \u003cp\u003eCrucially, the RevoFit\u0026trade; system is designed for dynamic volume management, but in this case, it also resulted in a significant long-term volume reduction. The 13.0% average reduction in maximum circumference measurements (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e) is a remarkable finding, suggesting that the consistent, patient-controlled pressure provided by the RevoFit\u0026trade; system acted as a highly effective, long-term compression therapy, leading to a profound reduction in chronic edema. This finding elevates the clinical significance of the adjustable socket beyond mere accommodation to active therapeutic management of residual limb volume. The dramatic drop in VAS score and the doubling of the step count confirm the success of this dynamic biomechanical intervention, fully justifying the use of the adjustable socket.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003e4.2. Maximizing Function within the K2 Classification\u003c/h2\u003e \u003cp\u003eThe decision to maintain the K2 classification post-intervention was deliberate and reflects a realistic assessment of the patient's overall health status (age, diabetes, comorbidities). However, the 100% increase in intermittent steps (from 450 to 900) represents a maximal functional gain within this classification. For a K2 ambulatory, the goal is not community ambulation (K3), but rather increased safety, efficiency, and duration of use within the home. The improved gait speed and step count indicate that the patient is utilizing the prosthesis more frequently and effectively for necessary daily activities, directly addressing the initial challenge of limited functional use. The profound improvement in QoL and satisfaction, which often correlates with increased use and comfort, underscores that for this patient population, the primary therapeutic goal is comfort and independence, not necessarily K-level advancement.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003e4.3. Ethical and Economic Implications\u003c/h2\u003e \u003cp\u003eThe success of this intervention highlights the potential of adjustable technology to improve patient outcomes and potentially reduce long-term healthcare costs. By eliminating the need for prolonged compression wrapping and potentially reducing the frequency of socket replacements or adjustments due to volume change, the RevoFit\u0026trade; system offers a compelling value proposition. Furthermore, the prosthetic\u0026rsquo;s initial assessment that this design provided the patient with the \"possibility of not undergoing new surgery\" suggests that effective, non-invasive volume management can be a critical factor in preserving limb health and function.\u003c/p\u003e \u003c/div\u003e"},{"header":"5. Study Limitations","content":"\u003cp\u003eAs a Single-Subject Clinical Case Report, the primary limitation is the inherent lack of generalizability. The results are specific to this patient's presentation, compliance, and the expertise of the clinical team. The K2 classification inherently limits the potential for dramatic functional gains. Future studies should focus on the long-term durability, maintenance, and cost-effectiveness of the adjustable system in a larger K2 cohort, particularly in comparison to other volume management strategies.\u003c/p\u003e"},{"header":"6. Future Directions","content":"\u003cp\u003eBased on the compelling positive outcomes observed in this single-subject case report, several avenues for future research are warranted to further validate and generalize the use of adjustable socket technology in the diabetic amputee population:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eLongitudinal Cohort Studies: Multi-center, prospective studies are needed to evaluate the long-term efficacy (12\u0026ndash;24 months) of the RevoFit\u0026trade; system in a larger cohort of K2 and K3 diabetic TTA patients, focusing on sustained reduction in volume fluctuation and maintenance of functional gains.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eCost-Effectiveness Analysis: Research should be conducted to determine the economic benefits of adjustable sockets by comparing the cost of the initial intervention against the reduced need for frequent socket replacements, adjustments, and the management of secondary complications (e.g., skin breakdown, ulceration) associated with poor fit.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eObjective Interface Pressure Monitoring: Future studies should integrate objective pressure sensors within the socket interface to quantify the effectiveness of the patient-controlled adjustment mechanism in maintaining a target pressure range across the daily activity cycle.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e"},{"header":"7. Conclusion","content":"\u003cp\u003eThe RevoFit\u0026trade; adjustable socket system is a highly valuable intervention for diabetic transtibial amputees, particularly those at the K2 functional level who suffer from significant, unstable residual limb edema. By providing patient-controlled volume compensation, the system drastically reduces the impact of volume fluctuation, leading to substantial improvements in comfort, functional activity (intermittent steps), and quality of life, thereby maximizing the patient's independence within their functional classification.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e The patient\u0026apos;s consent was obtained to share the data and description of the case.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e: I agree to publish\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e: applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e The author is the designer, socket manufacturer, and case supervisor.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e None.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions:\u003c/strong\u003e I am as an author read and approved the final manuscript\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgment\u003c/strong\u003e: I acknowledge Click Medical (Steamboat Springs, CO, USA) for technical knowledge exchange on engineering principles of adjustable mechanisms inspired by RevoSurface\u0026reg; technology, contributing to the conceptual development of the SL-STL scoliosis brace design..Click Medical provided no financial support or involvement in the study\u0026apos;s design, conduct, data collection, analysis, interpretation, or reporting; had no access to patient data; and remains neutral regarding this independent research.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eSanders JE, Fatone S. Residual limb volume change: systematic review of measurement and management. J Rehabil Res Dev. 2011;48(8):949-86. doi: 10.1682/jrrd.2010.09.0189\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eBaldock M, Pickard N, Prince M, Kirkwood S, Chadwell A, Howard D, et al. Adjustable prosthetic sockets: a systematic review of industrial and research design characteristics and their justifications. J Neuroeng Rehabil. 2023;20(1):147. doi: 10.1186/s12984-023-01270-0\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eBrzostowski JT, Larsen BG, Youngblood RT, Ciol MA, Hafner BJ, Gurrey CJ, et al. Adjustable sockets may improve residual limb fluid volume retention in transtibial prosthesis users. Prosthet Orthot Int. 2019;43(3):250-256. doi: 10.1177/0309364618820140\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"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":"Transtibial Amputation, Diabetes Mellitus, Residual Limb Edema, Adjustable Socket, RevoFit™, K2 Level, Case Report","lastPublishedDoi":"10.21203/rs.3.rs-8445528/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8445528/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eTranstibial amputation (TTA) in diabetic patients presents significant clinical challenges, particularly when complicated by unstable residual limb edema, leading to poor prosthetic fit, pain, and severely diminished quality of life. This report details the successful management of a complex 65-year-old male diabetic patient, classified as a K2 functional level (limited household ambulatory), who suffered from highly fluctuating stump volume. The patient was treated using the RevoFit\u0026trade; adjustable socket system (Click Medical). Pre-intervention, the patient reported high daily pain (VAS 6.5) and a daily step count of approximately 450 intermittent steps. A modified Patellar Tendon Bearing (PTB) socket was designed, integrating the RevoFit\u0026trade; system for immediate circumferential pressure control. Post-intervention results demonstrated a significant improvement within the K2 classification: average pain decreased to 1.2, the PEQ-QoL score increased from 35 to 88, and the daily step count increased to 900 intermittent steps. Crucially, the daily stump circumference fluctuation was reduced from 13.0% to 2.5%. This case report underscores the efficacy of adjustable socket technology in providing a practical solution for managing residual limb volume changes, thereby maximizing functional capacity and quality of life even within the limitations of the K2 functional level.\u003c/p\u003e","manuscriptTitle":"Clinical Case Report: Utilizing Adjustable Socket System for Managing Unstable Residual Limb Edema in a Complex Diabetic Transtibial Amputee","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-05 07:05:24","doi":"10.21203/rs.3.rs-8445528/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":"fc64be2c-49e3-4c40-9dfa-5265c3a0926f","owner":[],"postedDate":"January 5th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-01-06T19:15:08+00:00","versionOfRecord":[],"versionCreatedAt":"2026-01-05 07:05:24","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8445528","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8445528","identity":"rs-8445528","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}