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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 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.

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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.

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

FieldValue
Enrollment Target 120 participants
Start Date 2026-02-02
Est. Completion 2030-02-02
Phase NA

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT05437562

The ClinicalTrials.gov registry entry for NCT05437562 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (97% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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