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

患有周围动脉疾病并接受膝下截肢的退伍军人尤因截肢的试点研究

• 批准号: 10707110
• 负责人: LUKE Packard BREWSTER
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10707110
• 关键词: Accelerometer; Accounting; Affect; Agonist; Algorithms; Amputation; Amputees; Benchmarking; Benefits and Risks; Caring; Clinical; Clinical Research; Clinical Trials; Competence; Consent; Data; Diabetes Mellitus; Dissection; Enrollment; Equilibrium; Equipoise; Exclusion; Expert Opinion; Fall prevention; Femur; Funding; Gastrocnemius Muscle; Goals; Health; Individual; Informed Consent; Institution; Investigation; Knee; Lead; Limb structure; Literature; Love; Modification; Morbidity - disease rate; Muscle; Muscle Tension; Operative Surgical Procedures; Outcome; Pain; Pain management; Patients; Performance; Peripheral; Peripheral arterial disease; Phase; Phase 0 Study; Pilot Projects; Population; Postoperative Period; Proprioception; Prosthesis; Protocols documentation; Provider; Quality of life; Randomized; Research Personnel; Safety; Site; Surgeon; Surgical Wound Infection; Talents; Techniques; Testing; Time; Training; Veterans; Walking; antagonist; arm; care systems; chronic pain; design; feasibility testing; follow-up; improved; military veteran; mortality; muscle degeneration; neural; operation; pain outcome; pilot test; primary outcome; prosthesis fitting; randomized, clinical trials; recruit; regenerative; residual limb; safety outcomes; secondary outcome; wound healing

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)].

糖尿病和外周动脉疾病（PAD）不成比例地影响着我们国家的退伍军人，是最严重的疾病