Actively Recruiting
Randomized Clinical Trial for Ewing Amputation in the VA
Led by VA Office of Research and Development · Updated on 2026-02-09
120
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Randomized Clinical Trial for Ewing Amputation in the VA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans who have reasonable blood flow to heal a below knee amputation (palpable popliteal pulse or palpable femoral pulse with popliteal artery signal)
- Veterans expected to participate in rehabilitation and resume walking after amputation (based on interest, recent walking ability, and physical therapy evaluation)
- Veterans undergoing below knee amputation without active infection, or with fully treated infection below the ankle retinaculum
You will not qualify if you...
- Veterans with end-stage renal disease (ESRD)
- Veterans needing major amputation due to infection involving the ankle retinaculum
- Veterans with inadequate blood flow to heal a below knee amputation
- Veterans unable or not expected to participate in rehabilitation or walk with a prosthesis
- Veterans who were randomized for amputation of their other limb
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004
Actively Recruiting
2
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
Actively Recruiting
3
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
Research Team
L
Luke P Brewster, MD
CONTACT
M
Madhur Sancheti, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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