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)对我国退伍军人的影响不成比例，是 我们退伍军人重大截肢的主要贡献者。这些血管障碍的退伍军人经历了低于1000摄氏度 每年膝盖或经胫骨截肢。我们的退伍军人比年轻/健康的患者更有可能 伤口愈合时间长，疼痛，截肢后无法恢复活动状态。截肢 近几十年来，操作没有太大变化，但有许多令人兴奋的技术已经 已经发展起来，并具有改善退伍军人成果的潜力。尤文截肢(EA)是一种技术手段 经胫骨截肢的改良，可通过重建提供更好的肢体 激动剂拮抗剂在腓肠肌皮瓣下的肌神经界面(AMI)，并通过 再生周围神经再生接口(RPNI)的建立。EA已成功试运行 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 利用分阶段临床试验RFA首先在一小群退伍军人中测试电针的可行性 患者在一个VA部位。如果可行，3VA研究将随机比较电针和标准电针的结果 经胫骨截肢。主要的结果是用假肢行走。安全参数为30天 死亡率和股动脉截肢翻修率。次要结果是痛苦、平衡和质量 生活的一部分。积极的结果将在VAMC中广泛传播。通过这样做，我们将实现三方目标。 VHA截肢护理系统(ASOC)的目的是：1)提供最先进的护理；2)最大限度地提高健康和 独立；3)成为截肢退伍军人的首选提供者[退伍军人管理局指令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)].