Ewing Amputation in Veterans With PAD Undergoing BKA

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05437562
• Other study ID #: SURG-001-21F
• Secondary ID: CX002366-01A1
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: Luke P Brewster, MD
• Phone: (404) 321-6111
• Email: Luke.Brewster[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Ewing Amputation
All patients will receive Ewing Amputation to test feasibility.

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS Numeric Rating Scale	Patient reported rating scale to assess pain intensity and pain interference.	12 months
Primary	Socket Comfort Score	Patient reported rating scale to assess socket fit of prosthesis.	12 months
Primary	Phantom and Residual Limb Questionnaire	Patient reported questionnaire to assess sensation in phantom limb.	12 months
Primary	Lower Extremity Amputee Data Collection Form	Patient reported questionnaire to assess amputation system of care.	12 months
Primary	Lower Limb Mobility Rating Scale	Patient reported scale to assess movement with prosthetic leg.	12 months
Primary	Amputee Single Item Mobility Measure	Patient reported measure to assess current level of mobility.	12 months
Primary	Activities-specific Balance Scale	Patient reported scale to assess balance while performing every day activities.	12 months
Primary	Self-Reported Falls Measure	Patient reported one question survey to calculate falls in the previous month.	12 months
Primary	RAND Health Survey	Patient reported survey to assess general health while performing usual activities.	12 months
Primary	CRIS Fixed Form Instrument	Patient reported rating scale to assess usual activities in previous two weeks.	12 months
Primary	Patient Two Minute Walk Test	To measure distance patient can walk without assistance in 2 minutes.	12 months
Primary	Patient Timed Up and Go Test	To measure amount of time patient walks 3 meters.	12 months
Primary	Berg Balance Scale	To assess the patient's sitting and standing balance levels.	12 months
Primary	Amputee Mobility Predictor Questionnaire	To measure the patient's sitting, standing, turning and walking/stepping with and without prosthesis.	12 months