Randomized Clinical Trial for Ewing Amputation in the VA

February 4, 2026 updated by: VA Office of Research and Development

Pilot Investigation of Ewing Amputation in Veterans With Peripheral Arterial Disease Undergoing Below Knee Amputation

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Amputation System of Care (ASoC) are to: provide state of the art care, maximize health and independence, and to be the provider of choice for amputated Veterans. Veterans undergo ~1000 transtibial amputations (TTA) annually, making TTA a commonly performed operation in the VA. Almost all Veterans requiring TTA are dysvascular with peripheral artery disease (PAD) and/or diabetes. TTA is a safe operation with a low 30-day mortality rate, and ambulation with prosthesis rates are much better for TTA versus transfemoral amputations (TFA). Since ~50% of Veterans are satisfied with their ambulation after major amputation, improving ambulation is an important benchmark forward in the care of Veterans. Importantly, the lower ambulation rates in Veterans are attributed to modifiable sequelae of major amputation, including: slower wound healing9,10; chronic pain, imbalance, and falls. Excitingly, new techniques can improve pain and balance and may improve wound healing/prevent falls. Ewing amputation (EA) recreates the agonist-antagonist myoneural interface (AMI) maintaining muscle tension, proprioception and limiting fibrofatty muscle degeneration of muscle flaps. EA also creates regenerative peripheral neural interfaces (RPNI) to improve pain control. Thus, EA may have a significant benefit to Veterans undergoing TTA.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Decatur, Georgia, United States, 30033-4004
        • Recruiting
        • Atlanta VA Medical and Rehab Center, Decatur, GA
        • Principal Investigator:
          • Luke P Brewster, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37212-2637
        • Recruiting
        • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030-4211
        • Recruiting
        • Michael E. DeBakey VA Medical Center, Houston, TX
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ewing Amputation
Ewing Below Knee Amputation - incorporates RPNI and AMI
Procedure: Ewing Below Knee Amputation
Ewing Below Knee Amputation - incorporates RPNI and AMI
Experimental: Standard Below Knee Amputation
Procedure: Standard Below Knee Amputation
Standard Below Knee Amputation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Numeric Rating Scale
Time Frame: 12 months
Patient reported rating scale to assess pain intensity and pain interference.
12 months
Socket Comfort Score
Time Frame: 12 months
Patient reported rating scale to assess socket fit of prosthesis.
12 months
Phantom and Residual Limb Questionnaire
Time Frame: 12 months
Patient reported questionnaire to assess sensation in phantom limb.
12 months
Lower Extremity Amputee Data Collection Form
Time Frame: 12 months
Patient reported questionnaire to assess amputation system of care.
12 months
Lower Limb Mobility Rating Scale
Time Frame: 12 months
Patient reported scale to assess movement with prosthetic leg.
12 months
Amputee Single Item Mobility Measure
Time Frame: 12 months
Patient reported measure to assess current level of mobility.
12 months
Activities-specific Balance Scale
Time Frame: 12 months
Patient reported scale to assess balance while performing every day activities.
12 months
Self-Reported Falls Measure
Time Frame: 12 months
Patient reported one question survey to calculate falls in the previous month.
12 months
RAND Health Survey
Time Frame: 12 months
Patient reported survey to assess general health while performing usual activities.
12 months
CRIS Fixed Form Instrument
Time Frame: 12 months
Patient reported rating scale to assess usual activities in previous two weeks.
12 months
Patient Two Minute Walk Test
Time Frame: 12 months
To measure distance patient can walk without assistance in 2 minutes.
12 months
Patient Timed Up and Go Test
Time Frame: 12 months
To measure amount of time patient walks 3 meters.
12 months
Berg Balance Scale
Time Frame: 12 months
To assess the patient's sitting and standing balance levels.
12 months
Amputee Mobility Predictor Questionnaire
Time Frame: 12 months
To measure the patient's sitting, standing, turning and walking/stepping with and without prosthesis.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Luke P Brewster, MD, Atlanta VA Medical and Rehab Center, Decatur, GA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2026

Primary Completion (Estimated)

February 2, 2030

Study Completion (Estimated)

February 2, 2030

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SURG-001-21F
  • CX002366-01A1 (Other Grant/Funding Number: VA CSR&D Merit Award)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe