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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
United States
Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
RECRUITING
Decatur
Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
RECRUITING
Nashville
Texas
Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITING
Houston
Contact Information
Primary
Luke P Brewster, MD
Luke.Brewster@va.gov
(404) 321-6111
Backup
Madhur Sancheti, MS
madhur.sancheti@va.gov
(404) 321-6111
Time Frame
Start Date: 2026-02-02
Estimated Completion Date: 2030-02-02
Participants
Target number of participants: 120
Treatments
Experimental: Ewing Amputation
Ewing Below Knee Amputation - incorporates RPNI and AMI
Experimental: Standard Below Knee Amputation
Standard Below Knee Amputation
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov

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