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

糖尿病和外周动脉疾病（PAD）不成比例地影响我们国家的退伍军人， 是退伍军人截肢的主要原因这些血管障碍的退伍军人经历约1000以下 膝盖或经胫骨截肢。我们的退伍军人比年轻/健康的患者更有可能 遭受伤口愈合时间延长、疼痛和截肢后不能恢复行走状态。截肢 近几十年来，作战没有太大变化，但有许多令人兴奋的技术， 已经开发并具有改善退伍军人结果的潜力。尤因截肢术（EA）是一种技术性的 经胫骨截肢术的改良，通过重建 激动剂拮抗剂肌神经接口（AMI）腓肠肌皮瓣下，并改善疼痛控制， 再生外周神经再生接口（RPNI）的创建。EA已成功试点 在健康的高功能个体中进行了测试，但尚未在血管障碍患者中进行测试。这项建议 利用阶段性临床试验RFA的优势，首先在一小群退伍军人中测试EA的可行性， 患者在单一VA部位。如果可行，将进行一项3 VA研究，随机比较EA与标准的结果 经胫骨截肢主要结局是使用假体进行截肢。安全性参数为30天 死亡率和经股截肢翻修率。次要结局是疼痛、平衡和质量 生命积极的成果将在脆弱和易受伤害儿童管理中心广泛传播。这样做，我们将实现三方目标 VHA截肢护理系统（ASoC）：1）提供最先进的护理; 2）最大限度地提高健康水平， 独立性;和3）是截肢退伍军人的选择提供者[VHA指令1172.03（1）]。

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)].