Clinical trial NCT05437562: Randomized Clinical Trial for Ewing Amputation in the VA
Official title: Pilot Investigation of Ewing Amputation in Veterans With Peripheral Arterial Disease Undergoing Below Knee Amputation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Peripheral Arterial Disease
Keywords: amputation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-06-29
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: PROMIS Numeric Rating Scale
timeFrame: 12 months
measure: Socket Comfort Score
timeFrame: 12 months
measure: Phantom and Residual Limb Questionnaire
timeFrame: 12 months
measure: Lower Extremity Amputee Data Collection Form
timeFrame: 12 months
measure: Lower Limb Mobility Rating Scale
timeFrame: 12 months
measure: Amputee Single Item Mobility Measure
timeFrame: 12 months
measure: Activities-specific Balance Scale
timeFrame: 12 months
measure: Self-Reported Falls Measure
timeFrame: 12 months
measure: RAND Health Survey
timeFrame: 12 months
measure: CRIS Fixed Form Instrument
timeFrame: 12 months
measure: Patient Two Minute Walk Test
timeFrame: 12 months
measure: Patient Timed Up and Go Test
timeFrame: 12 months
measure: Berg Balance Scale
timeFrame: 12 months
measure: Amputee Mobility Predictor Questionnaire
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Nashville
country: United States
facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
state: Tennessee
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Luke P Brewster, MD
role: PRINCIPAL_INVESTIGATOR
References: