Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees (NCT05656924) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
United States38 participantsStarted 2023-12-20
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in intra-socket interface pressure between the two groups