Ewing Amputation for Peripheral Arterial Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byLuke P Brewster, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for Veterans with Peripheral Arterial Disease who need a below-knee amputation but have good blood flow to heal. They should be interested in rehabilitation and able to walk with a prosthesis after surgery. Those with severe kidney disease, major infections including the ankle, or poor blood flow not suitable for healing are excluded.

Inclusion Criteria

I am a veteran scheduled for or have had a below-knee amputation not due to infection, or I've had a treated foot infection below the ankle.

Veterans with good blood flow in the leg to heal a below-the-knee amputation.

I am a veteran planning to walk again and engage in physical therapy after my amputation.

Exclusion Criteria

I am a veteran needing a major amputation because of an infection that includes the ankle area.

Veterans who do not have enough blood flow to heal a below-the-knee amputation.

I am a veteran who cannot join in rehabilitation or use a prosthesis to walk.

+1 more

Participant Groups

The study tests Ewing Amputation (EA) feasibility over two years at AVAMC. It involves training surgeons in EA techniques and assessing their competence. Participants will undergo EA and follow a postoperative protocol for six months, aiming to recruit 30 Veterans and achieve at least 70% complete follow-up.

1Treatment groups

Experimental Treatment

Group I: Ewing AmputationExperimental Treatment2 Interventions

Randomized 1:1 clinical trial.