Recruiting

Ewing Amputation vs. Standard AmputationRandomized Clinical Trial for Ewing Amputation in the VA

Sponsor:

VA Office of Research and Development

Code:

NCT05437562

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Ewing Below Knee Amputation

Standard Below Knee Amputation

Study Details

Brief summary:

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.

Conditions

Peripheral Arterial Disease

Study ID

NCT05437562

Start date

Feb 2, 2026

Status verified date

Feb, 2026

Completion date

Feb 2, 2030

Anticipated

Primary completion date

Feb 2, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Ewing Amputation

Ewing Below Knee Amputation - incorporates RPNI and AMI

experimental: Standard Below Knee Amputation

Standard Below Knee Amputation

Interventions

Ewing Below Knee Amputation

Ewing Below Knee Amputation - incorporates RPNI and AMI

Standard Below Knee Amputation

Primary outcome measure

PROMIS Numeric Rating Scale [ Time Frame: 12 months ]
Socket Comfort Score [ Time Frame: 12 months ]
Phantom and Residual Limb Questionnaire [ Time Frame: 12 months ]
Lower Extremity Amputee Data Collection Form [ Time Frame: 12 months ]
Lower Limb Mobility Rating Scale [ Time Frame: 12 months ]
Amputee Single Item Mobility Measure [ Time Frame: 12 months ]
Activities-specific Balance Scale [ Time Frame: 12 months ]
Self-Reported Falls Measure [ Time Frame: 12 months ]
RAND Health Survey [ Time Frame: 12 months ]
CRIS Fixed Form Instrument [ Time Frame: 12 months ]
Patient Two Minute Walk Test [ Time Frame: 12 months ]
Patient Timed Up and Go Test [ Time Frame: 12 months ]
Berg Balance Scale [ Time Frame: 12 months ]
Amputee Mobility Predictor Questionnaire [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Luke P Brewster, MD

(404) 321-6111 Luke.Brewster@va.gov

Madhur Sancheti, MS

(404) 321-6111 madhur.sancheti@va.gov

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Recruiting

Decatur, Georgia, United States, 30033-4004

Contacts

Luke P Brewster, MD

404-321-6111 Luke.Brewster@va.gov

Principal Investigator:

Luke P Brewster, MD

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Recruiting

Nashville, Tennessee, United States, 37212-2637

Contacts

John A Curci, MD

615-873-7235 john.curci2@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Neal R Barshes, MD

713-791-1414 neal.barshes@va.gov

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

amputation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-09.