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NCT05437562 · ClinicalTrials.gov registry record · NA
Randomized Clinical Trial for Ewing Amputation in the VA
A NA study of Peripheral Arterial Disease, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 3
- Study locations
NCT05437562: Recruiting NA study of Peripheral Arterial Disease, sponsored by VA Office of Research and Development.
NCT05437562 is a NA study of Peripheral Arterial Disease that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 120 participants, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05437562, a NA study of Peripheral Arterial Disease, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study follows the Pilot Investigation of Ewing Amputation for Veterans with PAD Undergoing a Below Knee Amputation. The 2 year pilot feasibility phase has concluded recruitment and enrollment. The current phase is a 5 year randomized study of Ewing Below Knee Amputation vs. Standard Below Knee Amputation. If Veterans participate, they will be randomized to either Ewing Amputation or Standard Below Knee Amputation. The scientific premise motivating this proposal is that Ewing Amputation is a promising surgical technique that may improve walking metrics in dysvascular Veterans by providing a better residual limb and improving pain and balance. In preparation of this proposal, we have formed multi-disciplinary surgical teams at each site, and we have been supported by a clinical trial planning meeting to garner the considerable expertise in rehabilitation and amputee assessment from VA and DOD experts to assist in the design of this proposal, testing the overall hypothesis that: Ewing Amputation can help Veterans walk.
Primary Outcome
Patient reported rating scale to assess pain intensity and pain interference.
Conditions Studied
Interventions
- PROCEDURE Ewing Below Knee Amputation
- PROCEDURE Standard Below Knee Amputation
Study Locations (3)
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Tennessee
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN - Nashville
Texas
- Michael E. DeBakey VA Medical Center, Houston, TX - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2026-02-02 |
| Est. Completion | 2030-02-02 |
| Phase | NA |
What NCT05437562 shows while recruiting
NCT05437562 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which Ewing Below Knee Amputation is the first listed.
NCT05437562 reports a single indexed study location in Georgia, Tennessee, Texas.
Frequently Asked Questions
What is clinical trial NCT05437562 about?
NCT05437562 is a clinical study titled "Randomized Clinical Trial for Ewing Amputation in the VA". This study follows the Pilot Investigation of Ewing Amputation for Veterans with PAD Undergoing a Below Knee Amputation. The 2 year pilot feasibility phase has concluded recruitment and enrollment. The current phase is a 5 year randomized study of Ewing Below Knee Amputation vs. Standard Below Knee...
What is the current status of trial NCT05437562?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2026-02-02. Estimated completion is 2030-02-02.
What conditions does trial NCT05437562 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease.
What interventions are being tested in trial NCT05437562?
The interventions under investigation include: Ewing Below Knee Amputation (PROCEDURE), Standard Below Knee Amputation (PROCEDURE).
Who is sponsoring clinical trial NCT05437562?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05437562 being conducted?
This trial has 3 study locations across Georgia, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05437562's enrollment target sits among peer trials
120 34th of 79 higher than 46 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease 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.
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