Ewing Amputation in Veterans With PAD Undergoing BKA

VA Office of Research and Development

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Other: Ewing Amputation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05437562

SURG-001-21F

CX002366-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

The objective is to quantify in 2 years the feasibility of recruiting and retaining Veterans at the AVAMC in an EA protocol. The investigators will implement a training protocol for AMI and RPNI. The investigators will document competence and timing to competence for the AVAHCS surgical team. The investigators will perform EA in AVAHCS Veterans who meet inclusion/exclusion parameters and elect EA surgical intervention. Veterans will then participate in the investigators' postoperative protocol out to 6 months. The criteria to moving to phase 2 includes clinically consenting and and performing EA in 30 Veterans and collecting 6 months follow up data over 18 months at AVAHCS and 70% or better complete follow-up at 6 month time point after operation.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Ewing Amputation

Other group

Description:

Single Arm Pilot Study : To implement lead-in surgeon training and test the feasibility of recruiting and retention of veterans undergoing Ewing Amputation in a single arm study at Atlanta VAMC.

Treatment:

Other: Ewing Amputation