Ewing Amputation for Veterans with Peripheral Arterial Disease

This study is for Veterans with Peripheral Arterial Disease (PAD), a condition where narrowed arteries reduce blood flow to the limbs, who need a below-knee amputation. It compares two types of surgery: Ewing Below Knee Amputation and Standard Below Knee Amputation. The Ewing amputation is a newer technique that aims to improve walking, reduce pain, and improve balance by maintaining muscle tension and sensation in the limb. Researchers want to see if the Ewing amputation helps Veterans walk better and feel more comfortable with their prosthetic leg, and if it reduces phantom limb pain (pain felt in a missing limb). You may be able to join if you are a Veteran with reasonable blood flow for healing and can participate in rehabilitation. This study is currently recruiting 120 participants.

Study design
This is a randomized study, meaning you would be assigned by chance to receive either the Ewing Below Knee Amputation or the Standard Below Knee Amputation. The study plans to enroll 120 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your comfort and pain will be measured at 12 months after the amputation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05437562

Randomized Clinical Trial for Ewing Amputation in the VA

Recruiting
NAAll AgesInterventional
VA Office of Research and Development
~120 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:Ewing Below Knee AmputationStandard Below Knee Amputation

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PROMIS Numeric Rating Scale
Measured over 12 months
+13 more outcomes measured
Peripheral Arterial Disease
3 sites across 3 states
Georgia1
Tennessee1
Texas1
  • Luke P Brewster, MD · PRINCIPAL_INVESTIGATOR · Atlanta VA Medical and Rehab Center, Decatur, GA

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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)
  • PROMIS Numeric Rating Scale12 months

    Patient reported rating scale to assess pain intensity and pain interference.

  • Socket Comfort Score12 months

    Patient reported rating scale to assess socket fit of prosthesis.

  • Phantom and Residual Limb Questionnaire12 months

    Patient reported questionnaire to assess sensation in phantom limb.

  • Lower Extremity Amputee Data Collection Form12 months

    Patient reported questionnaire to assess amputation system of care.

  • Lower Limb Mobility Rating Scale12 months

    Patient reported scale to assess movement with prosthetic leg.

  • Amputee Single Item Mobility Measure12 months

    Patient reported measure to assess current level of mobility.

  • Activities-specific Balance Scale12 months

    Patient reported scale to assess balance while performing every day activities.

  • Self-Reported Falls Measure12 months

    Patient reported one question survey to calculate falls in the previous month.

  • RAND Health Survey12 months

    Patient reported survey to assess general health while performing usual activities.

  • CRIS Fixed Form Instrument12 months

    Patient reported rating scale to assess usual activities in previous two weeks.

  • Patient Two Minute Walk Test12 months

    To measure distance patient can walk without assistance in 2 minutes.

  • Patient Timed Up and Go Test12 months

    To measure amount of time patient walks 3 meters.

  • Berg Balance Scale12 months

    To assess the patient's sitting and standing balance levels.

  • Amputee Mobility Predictor Questionnaire12 months

    To measure the patient's sitting, standing, turning and walking/stepping with and without prosthesis.