Clinical Trial

Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The study will test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb secondary to diabetes mellitus type II (herein referred to as dysvascular amputees). The technology-based intervention will be combined with an exercise program designed to improve the health status of dysvascular amputees.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-12-08; most recent amendment 2026-04-22.
Status change: Recruiting → Active, Not Recruiting 2026-04-22
Status change: Not Yet Recruiting → Recruiting 2024-06-19
Trial Details
NCT Number NCT05656924
Lead Sponsor Spaulding Rehabilitation Hospital
Collaborators: Bionic Skins LLC, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Diabetes Type 2, Amputation
Enrollment 38 participants
Start Date 2023-12-20
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-28