Status:
NOT_YET_RECRUITING
Randomized Clinical Trial for Ewing Amputation in the VA
Lead Sponsor:
VA Office of Research and Development
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
Phase:
NA
Brief 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. T...
Detailed Description
Major amputations lead to significant challenges for Veterans and their loved ones. Thus, amputations and the care of amputees are a major focus of the VHA. Hence, the tripartite goals of the VHA Ampu...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Veterans with end-stage renal disease (ESRD)
- Veterans requiring major amputation due to infection that includes the ankle retinaculum
- Veterans deemed to have inadequate blood flow to heal a TTA
- Veterans who cannot participate in rehabilitation or are not expected to be able to ambulate with a prosthesis for any reason
- Veterans who were randomized for their other limb (to prevent Veteran from the possibility of having 2 different amputations)
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2030
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05437562
Start Date
January 15 2026
End Date
January 15 2030
Last Update
December 31 2025
Active Locations (3)
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1
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004
2
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
3
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211