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Randomized Clinical Trial for Ewing Amputation in the VA
Sponsor: VA Office of Research and Development
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
Conditions
Interventions
Ewing Below Knee Amputation
Ewing Below Knee Amputation - incorporates RPNI and AMI
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