Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
Running, not enrolling · Phase 2
Conditions studied: Diabetes Type 2, Amputation
In brief
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.
Key facts
- Study ID
- NCT05656924
- Run by
- Spaulding Rehabilitation Hospital
- People needed
- 38
- Starts
- 2023-12-20
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-04-28
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Unilateral transtibial amputation within the past 6 years
- Etiology secondary to complications of Diabetes Mellitus (DM) type II
- Current use of a prosthesis, with at least 2 months prior use
- K2 or K3 level (as determined using the Amputee Mobility Predictor assessment tool)
- Own a smartphone
You may not qualify if…
- 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
Where it is running
- Spaulding Rehabilitation Hospital Boston — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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