RecruitingNot ApplicableNCT05437562

Randomized Clinical Trial for Ewing Amputation in the VA

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

Sponsor

VA Office of Research and Development

Enrollment

120 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Peripheral Arterial Disease

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.

Eligibility

Inclusion Criteria3

Veterans who have reasonable blood flow to heal a TTA (defined as palpable popliteal pulse or palpable femoral pulse with popliteal artery signal)
Veterans with an expectation of participating in rehabilitation and resuming ambulation after amputation (defined by the Veteran interest, recent ambulation by the Veteran, ability to participate in physical therapy as deemed by the investigators' physical therapy team)
Veterans who will be undergoing below knee amputation for reasons other than infection (uninfected patients) or Veterans who have had foot infection localized below the ankle (retinaculum uninfected) that has been adequately debrided and treated with appropriate antibiotic course.

Exclusion Criteria5

Veterans with end-stage renal disease (ESRD)
Veterans requiring major amputation due to infection that includes the ankle retinaculum
Veterans deemed to have inadequate blood flow to heal a TTA
Veterans who cannot participate in rehabilitation or are not expected to be able to ambulate with a prosthesis for any reason
Veterans who were randomized for their other limb (to prevent Veteran from the possibility of having 2 different amputations)

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