Randomized Clinical Trial for Ewing Amputation in the VA

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: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: Standard Below Knee Amputation; Procedure: Ewing Below Knee Amputation

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

• Study Contact: Name: Luke P Brewster, MD; Phone Number: 7084 (404) 321-6111; Email: Luke.Brewster@va.gov
• Study Contact Backup: Name: Madhur Sancheti, MS; Phone Number: 206478 (404) 321-6111; Email: madhur.sancheti@va.gov

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: Luke P Brewster, MD; Phone Number: 7084 404-321-6111; Email: Luke.Brewster@va.gov
  • Tennessee
    • Nashville, Tennessee, United States, 37212-2637
      • Recruiting
      • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
      • Contact: John A Curci, MD; Phone Number: 615-873-7235; Email: john.curci2@va.gov
  • Texas
    • Houston, Texas, United States, 77030-4211
      • Recruiting
      • Michael E. DeBakey VA Medical Center, Houston, TX
      • Contact: Neal R Barshes, MD; Phone Number: 25188 713-791-1414; Email: neal.barshes@va.gov

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• 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

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: amputation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• 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