Randomized Clinical Trial for Ewing Amputation in the VA

Part of paid clinical trials in Decatur, Georgia.

Sponsor
VA Office of Research and Development
Study ID
NCT05437562
Status
Recruiting
Apply to this trial

Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ewing Below Knee Amputation — PROCEDURE
    Ewing Below Knee Amputation - incorporates RPNI and AMI
  • Standard Below Knee Amputation — PROCEDURE
    Standard Below Knee Amputation

Study Details

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.

Key Dates

Start date
Feb 2, 2026
Status verified
Feb 2026
Primary completion
Feb 2, 2030
Completion
Feb 2, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Ewing Amputation
    Ewing Below Knee Amputation - incorporates RPNI and AMI
  • Experimental: Standard Below Knee Amputation
    Standard Below Knee Amputation

Primary Outcome Measure

PROMIS Numeric Rating Scale [ Time Frame: 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004
Luke P Brewster, MD
[email protected]
404-321-6111
Luke P Brewster, MD (PRINCIPAL_INVESTIGATOR)
Tennessee Valley Healthcare System Nashville Campus, Nashville, TNNashvilleTennessee37212-2637
John A Curci, MD
[email protected]
615-873-7235
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Neal R Barshes, MD
[email protected]
713-791-1414

Find similar trials in Decatur, GA

By research site
Atlanta VA Medical and Rehab Center, Decatur, GA· Decatur, GATennessee Valley Healthcare System Nashville Campus, Nashville, TN· Nashville, TNMichael E. DeBakey VA Medical Center, Houston, TX· Houston, TX

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