๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-04

Randomized Clinical Trial for Ewing Amputation in the VA (NCT05437562)

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

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿฉบ Clinical Procedure Protocol Sponsor: VA Office of Research and Development

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Atlanta VA Medical and Rehab Center, Decatur, GA โ€” Decatur, Georgia

๐Ÿงช Interventions in This Study

  • Ewing Below Knee Amputation (PROCEDURE)
  • Standard Below Knee Amputation (PROCEDURE)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (3 Sites)

  • Atlanta VA Medical and Rehab Center, Decatur, GA โ€” Decatur, Georgia
  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN โ€” Nashville, Tennessee
  • Michael E. DeBakey VA Medical Center, Houston, TX โ€” Houston, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (404) 321-6111

Email: Luke.Brewster@va.gov

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—