Randomized Clinical Trial for Ewing Amputation in the VA

NCT05437562 | Recruiting DMC

• 2 other identifiers: SURG-001-21FCX002366-01A1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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

Keywords

amputation

Outcome Measures

Primary Outcomes (14)

• 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

Study Arms (2)

Ewing Amputation

EXPERIMENTAL

Ewing Below Knee Amputation - incorporates RPNI and AMI

Procedure: Ewing Below Knee Amputation

Standard Below Knee Amputation

EXPERIMENTAL

Standard Below Knee Amputation

Procedure: Standard Below Knee Amputation

Interventions

Ewing Below Knee Amputation PROCEDURE

Ewing Below Knee Amputation - incorporates RPNI and AMI

Ewing Amputation

Standard Below Knee Amputation PROCEDURE

Standard Below Knee Amputation

Standard Below Knee Amputation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

RECRUITING

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

RECRUITING

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Luke P Brewster, MD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luke P Brewster, MD

CONTACT

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

Madhur Sancheti, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This study is evaluating an intervention in surgical technique for below knee amputation. The Veterans will be randomized to either Ewing amputation, which is a nuanced approach that incorporates RPNI and AMI to the standard below knee amputation. The standard below knee amputation is the comparison technique.

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 29, 2022
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 2, 2030
• Study Completion (Estimated): February 2, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)