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RECRUITING
NCT05437562
NA

Randomized Clinical Trial for Ewing Amputation in the VA

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: Pilot Investigation of Ewing Amputation in Veterans With Peripheral Arterial Disease Undergoing Below Knee Amputation

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-02-02

Completion Date

2030-02-02

Last Updated

2026-02-09

Healthy Volunteers

No

Interventions

PROCEDURE

Ewing Below Knee Amputation

Ewing Below Knee Amputation - incorporates RPNI and AMI

PROCEDURE

Standard Below Knee Amputation

Standard Below Knee Amputation

Locations (3)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States