Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees (NCT05656924)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).
Location: Spaulding Rehabilitation Hospital Boston — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Amputation due to cancer or macrotrauma or acute hemorrhage
- Bilateral amputation
- Medically or surgically unstable contralateral lower extremity as determined by medical criteria (e.g., critical limb ischemia)
- Severe residual limb pain that limits function preventing participation in an exercise-based program
- Medical conditions that would interfere with subject's participation in regular sustained exercise
- Anthropometric characteristics that are not compatible with the technology used to scan the residuum and manufacture the liner and socket (e.g., a residuum circumference greater than 32 inches would not be compatible with the device used to scan the residuum)
- Current pregnancy
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Spaulding Rehabilitation Hospital Boston — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.