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
๐ฉบ 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
๐งช Interventions in This Study
- Ewing Below Knee Amputation (PROCEDURE)
- Standard Below Knee Amputation (PROCEDURE)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ 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.
๐ฐ 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.
More studies in Peripheral Arterial Disease
- SELUTION4SFA Trial โ Little Rock, Arkansas
- SCOPE-CLI: Shifting Care and Outcomes for Patients With Endangered Limbs โ New Haven, Connecticut
- A Clinical Evaluation of the MicroSTentยฎ PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND) โ Birmingham, Alabama
- Shortwave Diathermy In-home Treatment for Indianapolis VA-only Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy โ Indianapolis, Indiana
- FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease โ Chicago, Illinois
- MitoQ Treatment of Claudication: Myofiber and Micro-vessel Pathology โ Omaha, Nebraska
Explore by condition: All Peripheral Arterial Disease clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.