Ewing below-knee amputation versus standard below-knee amputation for Veterans with peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.