Restoring Mobility in Diabetic Peripheral Neuropathy: Implementation of a Novel, Wearable Sensory Prosthesis for Plantar Sensory Loss

Introduction and Objective: Diabetic peripheral neuropathy (PN) causes loss of plantar sensation, leading to balance impairment and increased fall risk, yet few interventions exist to address this. Walkasins (HCPCS L8720/L8721) is a novel wearable sensory prosthesis worn on the ankle that measures plantar pressure via an in-shoe footpad and delivers direction-specific haptic stimuli to replace part of lost plantar sensory information during standing and walking. This study describes the real-world effect of Walkasins on self-reported physical function over 12 weeks. Methods: A US-wide registry was created of adults with type 1 or type 2 diabetes (T1D or T2D) prescribed Walkasins between 2022 and 2025. Registrants had a PN diagnosis with confirmed loss of plantar sensation, gait and balance deficits, and preserved tactile sensitivity around the ankle. Self-reported physical function was assessed via phone-based, validated Patient-Specific Functional Scale (PSFS) at device initiation (baseline) and after 12 weeks of use. PSFS scores of were compared with Wilcoxon signed-rank test (p=0.05). Results: Of 2,998 registrants with diabetes prescribed Walkasins, 722—across 46 states—completed the 12-week PSFS assessment (T2D: 96.5%; mean (SD) age: 76.2±8.1 years; male: 97%). 92% of participants reported using the device 3-7 days/week. PSFS mean±SD scores improved from 3.36±1.92 at baseline to 6.94±2.24 at 12 weeks (p<0.001). The three most reported functional concerns were related to walking, e.g. “walking across a room”, “walking without support”, and “walking on uneven ground” (n=620, 85.6%). Conclusion: In this large, real-world registry study, Walkasins use was associated with statistically significant and clinically meaningful improvements in self-reported physical function over 12 weeks, with PSFS scores doubling from baseline. Gains were most pronounced in walking-related tasks. Findings support Walkasins as a promising, patient-centered intervention for individuals with diabetic PN. Disclosure: L. Oddsson: Employee; Current; RxFunction Inc. A. Ratzki-Leewing: Advisory Panel; Current; Sanofi. Consultant; Current; Vertex Pharmaceuticals Incorporated, Dexcom, Inc. Research Support; Current; Sanofi. Other - Paid presentation; Ended; Abbott. Consultant; Current; Sanofi. S.B. Richmond: Employee; Current; RxFunction Inc. D. Orwig: None. N. Latham: None.