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

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Diabetes and peripheral arterial disease (PAD) disproportionately affect our nation’s Veterans and are the major contributors to major amputation in our Veterans. These dysvascular Veterans undergo ~ 1000 below the knee or transtibial amputations annually. Our Veterans are more likely than younger/healthier patients to suffer from prolonged wound healing, pain, and not regaining ambulatory status after amputation. Amputation operations have not changed much in recent decades, but there are a number of exciting techniques that have been developed and hold potential for improving Veteran outcomes. Ewing amputation (EA) is a technical modification of transtibial amputation that may be able to provide a better limb for ambulation by recreating agonist antagonist myoneural interface (AMI) under the gastrocnemius flap and improve pain control through the creation of regenerative peripheral neural regenerative interfaces (RPNI). EA has been successfully pilot tested in healthy, high-functioning individuals, but it has not been tested in dysvascular patients. This proposal takes advantage of the phased clinical trial RFA to first test feasibility of EA in Veterans in a small group of patients at a single VA site. If feasible, a 3 VA study will randomly compare the results of EA versus standard transtibial amputation. The primary outcome is ambulation with a prosthesis. Safety parameters are 30-day mortality and rate of revision to transfemoral amputation. Secondary outcomes are pain, balance, and quality of life. Positive results will be disseminated across VAMCs broadly. In so doing, we will meet the tripartite goals of the VHA Amputation System of Care (ASoC) to: 1) provide state of the art care; 2) maximize health and independence; and 3) be the provider of choice for amputated Veterans [VHA Directive 1172.03(1)].