Ewing below-knee amputation versus standard below-knee amputation for Veterans with peripheral artery disease
Pilot Investigation of Ewing Amputation in Veterans With Peripheral Arterial Disease Undergoing Below Knee Amputation
NA · VA Office of Research and Development · NCT05437562
This trial will randomize Veterans with PAD who need a below-knee amputation to try the Ewing amputation or the standard below-knee amputation to see which leads to better walking, less pain, and improved balance.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 3 sites (Decatur, Georgia and 2 other locations) |
| Trial ID | NCT05437562 on ClinicalTrials.gov |
What this trial studies
This is a randomized, multicenter 5-year study comparing the Ewing below-knee amputation to the standard below-knee amputation in Veterans with peripheral artery disease. The Ewing technique recreates the agonist–antagonist myoneural interface (AMI) and uses regenerative peripheral neural interfaces (RPNIs) to preserve muscle tension and improve nerve-related pain, with the goal of improving proprioception, balance, and wound outcomes. Participants will be randomized at VA centers and followed with measures of walking metrics, pain, balance, wound healing, and prosthetic use while receiving standard rehabilitation. The trial builds on a completed pilot feasibility phase and uses multidisciplinary surgical and rehabilitation teams at each site.
Who should consider this trial
Good fit: Veterans with PAD who are scheduled for a planned below-knee amputation, have adequate blood flow to heal the residual limb, and can participate in postoperative rehabilitation are ideal candidates.
Not a fit: Patients with inadequate blood flow to heal a transtibial amputation, major ankle-area infection, end-stage renal disease, or inability to participate in rehabilitation are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, Ewing amputation could improve walking ability, reduce chronic pain, and lower fall risk compared with standard below-knee amputation.
How similar studies have performed: A completed pilot feasibility phase in Veterans suggested the Ewing procedure is promising for improving function and pain, but randomized evidence is limited and this study is one of the first larger randomized comparisons.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Decatur, Georgia and 2 other locations
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (RECRUITING)
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee, United States (RECRUITING)
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Luke P Brewster, MD — Atlanta VA Medical and Rehab Center, Decatur, GA
- Study coordinator: Luke P Brewster, MD
- Email: Luke.Brewster@va.gov
- Phone: (404) 321-6111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Arterial Disease, amputation