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Randomized Clinical Trial for Ewing Amputation in the VA
NCT05437562 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05437562
The ClinicalTrials.gov registry entry for NCT05437562 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05437562 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Georgia, Tennessee, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05437562?
The interventions under investigation include: Ewing Below Knee Amputation (PROCEDURE), Standard Below Knee Amputation (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05437562?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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