Ewing amputation compared with standard below knee amputation in veterans with peripheral arterial disease
Compares two types of below knee amputation in veterans with peripheral arterial disease.
Key facts
- Who runs it
- VA Office of Research and Development
- Where
- Decatur, Houston, and Nashville, United StatesSee the 3 sites
- Trial code
- Registry title
- Randomized Clinical Trial for Ewing Amputation in the VA
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 2 Feb 2026
- Expected to end
- 2 Feb 2030
- Type of study
- Interventional, 2 groups
- Treatments tested
- Ewing Below Knee Amputation
- Standard Below Knee Amputation
- Record updated
- 9 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for Veterans with peripheral arterial disease (poor blood flow in the legs) who will have a below knee amputation. People are randomly put into the Ewing amputation group or the standard amputation group.
- Sex
- All sexes can join.
- Disease stage
- Peripheral arterial disease needing a below knee amputation. There must be enough blood flow for the wound to heal (a pulse felt behind the knee, or a pulse felt in the groin with a blood flow signal behind the knee). The amputation must not be for infection, unless a foot infection stayed below the ankle and was cleaned out and treated with antibiotics.
Main reasons for not taking part
- End-stage kidney disease (ESRD)
- Infection that reaches the ankle and requires the amputation
- Not enough blood flow for the wound to heal
- Not able to take part in rehabilitation or not expected to walk with an artificial leg
- Already randomized in this trial for the other leg
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
Where in United States
- Atlanta VA Medical and Rehab Center, Decatur, GADecatur, United StatesContact: Luke P Brewster, MDTaking people
- Michael E. DeBakey VA Medical Center, Houston, TXHouston, United StatesContact: Neal R Barshes, MDTaking people
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TNNashville, United StatesContact: John A Curci, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Ewing AmputationTreatment being tested
Ewing Below Knee Amputation - incorporates RPNI and AMI
Treatment: Ewing Below Knee Amputation
- Standard Below Knee AmputationTreatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pilot Investigation of Ewing Amputation in Veterans With Peripheral Arterial Disease Undergoing Below Knee Amputation
- Plain-language title
- Ewing amputation compared with standard below knee amputation in veterans with peripheral arterial diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 9 February 2026