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NCT05656924 · ClinicalTrials.gov registry record · Phase 2
Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees
A Phase 2 study of Amputation and Diabete Type 2, sponsored by Spaulding Rehabilitation Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT05656924: Recruiting Phase 2 study of Amputation and Diabete Type 2, sponsored by Spaulding Rehabilitation Hospital.
NCT05656924 is a Phase 2 study of Amputation and Diabete Type 2 that is actively recruiting participants, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 38 participants, below the 132-participant average among 65 other Amputation trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05656924, a Phase 2 study of Amputation and Diabete Type 2, is actively recruiting participants, sponsored by Spaulding Rehabilitation Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Pressure sensors inserted in the socket will be used to measure the pressure on the residuum when study participants are weight bearing. The pressure is measured in kilopascals (kPa). 1 kPa is approximately the pressure exerted by a 10-g mass resting on a 1-cm2 area.
Conditions Studied
Interventions
- DEVICE digital prosthetic interface technology
Study Locations (1)
Massachusetts
- Spaulding Rehabilitation Hospital Boston - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What NCT05656924 shows while recruiting
NCT05656924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 132-participant average among 65 other Amputation trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Amputation appearing as the primary indexed condition, and to 1 intervention - of which digital prosthetic interface technology is the first listed.
NCT05656924 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05656924 about?
NCT05656924 is a clinical study titled "Deploying Digital Prosthetic Interface Technology and Exercise in Dysvascular Amputees". 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 des...
What is the current status of trial NCT05656924?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2023-12-20. Estimated completion is 2026-12-31.
What conditions does trial NCT05656924 study?
This clinical trial studies the following conditions: Amputation, Diabete Type 2.
What interventions are being tested in trial NCT05656924?
The interventions under investigation include: digital prosthetic interface technology (DEVICE).
Who is sponsoring clinical trial NCT05656924?
This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05656924 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amputation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05656924's enrollment target sits among peer trials
38 25th of 65 higher than 41 of 65 other Amputation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amputation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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