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NCT Number: NCT05437562

Randomized Clinical Trial for Ewing Amputation in the VA

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ewing Below Knee Amputation

Procedure

Ewing Below Knee Amputation - incorporates RPNI and AMI

Standard Below Knee Amputation

Procedure

Standard Below Knee Amputation

Primary outcomes

  1. PROMIS Numeric Rating Scale

    Time frame: 12 months

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

  2. Socket Comfort Score

    Time frame: 12 months

    Patient reported rating scale to assess socket fit of prosthesis.

  3. Phantom and Residual Limb Questionnaire

    Time frame: 12 months

    Patient reported questionnaire to assess sensation in phantom limb.

  4. Lower Extremity Amputee Data Collection Form

    Time frame: 12 months

    Patient reported questionnaire to assess amputation system of care.

  5. Lower Limb Mobility Rating Scale

    Time frame: 12 months

    Patient reported scale to assess movement with prosthetic leg.

  6. Amputee Single Item Mobility Measure

    Time frame: 12 months

    Patient reported measure to assess current level of mobility.

  7. Activities-specific Balance Scale

    Time frame: 12 months

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

  8. Self-Reported Falls Measure

    Time frame: 12 months

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

  9. RAND Health Survey

    Time frame: 12 months

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

  10. CRIS Fixed Form Instrument

    Time frame: 12 months

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

  11. Patient Two Minute Walk Test

    Time frame: 12 months

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

  12. Patient Timed Up and Go Test

    Time frame: 12 months

    To measure amount of time patient walks 3 meters.

  13. Berg Balance Scale

    Time frame: 12 months

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

  14. Amputee Mobility Predictor Questionnaire

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Luke P Brewster, MD

CONTACT

[email protected]

(404) 321-6111 ext. 7084

Madhur Sancheti, MS

CONTACT

[email protected]

(404) 321-6111 ext. 206478

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 29, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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