NCT05656924Active, not recruitingPhase 2
Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
Improving the Health Status of Dysvascular Amputees by Deploying Digital Prosthetic Interface Technology in Combination With an Exercise Intervention
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 8 Dec 2022
- Start date
- 20 Dec 2023
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT05656924
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 38
- From 20 Dec 2023 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Amputation due to cancer or macrotrauma or acute hemorrhage
- Medical conditions that would interfere with subject's participation in regular sustained exercise
Other
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Spaulding Rehabilitation Hospital Boston Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.