Clinical study of a wearable therapeutic ultrasound sleeve for treatment of neuro-ischemic and ischemic diabetic foot ulcers

可穿戴超声治疗套治疗神经缺血性和缺血性糖尿病足溃疡的临床研究

• 批准号: 10383532
• 负责人: Juliana Elstad
• 金额: $ 30万
• 依托单位: VIBRATO MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10383532
• 关键词: Acoustics; Acute; Address; Adoption; Advanced Glycosylation End Products; Adverse event; Ambulatory Care; Amputation; Animal Model; Arteries; Beds; Blood; Blood flow; Clinic Visits; Clinical; Clinical Research; Clinical Trials Design; Controlled Clinical Trials; Coronary Arteriosclerosis; Data; Debridement; Devices; Diabetes Mellitus; Diabetic Foot Ulcer; Diagnosis; Disease; Dose; Etiology; Excision; Family; Feasibility Studies; Feedback; Gangrene; Goals; Growth; Hand; Health Care Costs; Health Personnel; Healthcare Systems; Hemoglobin; Home; Hospitalization; Human; Human Resources; Image; Impaired wound healing; Improve Access; Infection; Ischemia; Lasers; Leg; Lower Extremity; Measurement; Measures; Mediating; Medical; Modality; Muscle; Operative Surgical Procedures; Outcome; Oxygen; Patients; Perfusion; Perioperative; Peripheral arterial disease; Phase; Play; Population; Prevalence; Process; Productivity; Prospective Studies; Quality of life; Questionnaires; Recurrence; Response Elements; Risk; Role; Safety; Serious Adverse Event; Small Business Innovation Research Grant; Sonication; Spatial Frequency Domain Imaging; Standardization; Structure; Symptoms; Therapeutic; Tissues; Touch sensation; Training; Ultrasonic Therapy; Vasodilation; angiogenesis; autonomic neuropathy; bone; care burden; chronic wound; clinical effect; clinical efficacy; cost; diabetic; experience; first-in-human; foot; healing; healthy volunteer; high risk; human data; human study; improved; novel; open label; portability; pressure; prevent; prospective; response; restoration; therapy design; tissue oxygenation; treatment duration; trial design; ultrasound; wound healing

PROJECT SUMMARY Diabetes mellitus (DM) is a common condition (34M in USA). Approximately 1 in 7 DM patients have diabetic foot ulcers (DFU). Approximately half of patients with DFU have concomitant peripheral arterial disease (PAD), resulting in US prevalence of 2.5M patients with ischemic or neuroischemic DFUs. Patients with DFUs experience recurrent hospitalizations, chronic wound healing issues, and ultimately amputations that severely limit quality of life and productivity and place a significant burden of care on families and a sizable cost for the healthcare system. The patients with DFUs experience either some bone removal (750K to 1.35M ) or amputation (170K) annually, making new options necessary to treat these patients and prevent the costly amputations and hospitalizations. Patients with DFU’s who also have PAD experience these symptoms because of poor blood flow both in the larger arteries delivering blood to the lower leg and in the smaller vessels branching out to supply the muscles and tissues of the lower leg and foot. Acoustic energy modalities such as therapeutic ultrasound (TUS) have been shown to promote collateral vessel growth, angiogenesis, and to improve perfusion in animal models of coronary artery disease and PAD, with promising early human data in both disease processes. Vibrato Medical has developed a novel treatment with the first wearable therapeutic ultrasound (TUS) device for the non-invasive, outpatient treatment of PAD that will promote collateral vessel growth and angiogenesis, restore perfusion and reduce amputation rates. We have already demonstrated VibratoSleeve’s efficacy in markedly improving lower extremity perfusion in healthy volunteers using multiple perfusion measures. The goal of this Phase I SBIR proposal is to conduct a prospective open-label clinical trial designed to evaluate the acute improvement in perfusion to ischemic or neuro-ischemic DFUs. A total of 12 subjects will receive wearable VibratoSleeve treatment to the posterior calf for 90 minutes at 3 separate clinic visits at low, medium and high acoustic intensity settings. Efficacy will be assessed by comparing baseline and on- therapy, and mean improvements in each endpoint will be compared across all 3 intensities to determine a dose-response relationship. We will also systematically obtain patient feedback on ease of use, tolerability, and comfort of VibratoSleeve using a standardized questionnaire administered after each 90-minute treatment. Data on the tactile sensation and comfort will inform optimal acoustic parameters, treatment duration and design of a subsequent sham-controlled clinical trial of long-term TUS therapy to assess DFU healing.

项目概要 糖尿病 (DM) 是一种常见疾病（美国有 3400 万糖尿病患者）。 足部溃疡（DFU）。大约一半的 DFU 患者伴有外周动脉疾病（PAD）， 导致美国有 250 万缺血性或神经缺血性 DFU 患者患病率。 经历反复住院、慢性伤口愈合问题，并最终严重截肢 限制了生活质量和生产力，给家庭带来沉重的照顾负担和相当大的医疗费用 患有 DFU 的患者经历了一些骨质去除（750K 至 1.35M）或 每年截肢 (170K)，需要新的选择来治疗这些患者并防止昂贵的费用 患有 DFU 且患有 PAD 的患者会出现截肢和住院治疗。 因为流向小腿的大动脉和小腿的血液流动都很差 血管分支，供应小腿和足部的肌肉和组织。 超声治疗 (TUS) 等声能模式已被证明可以促进侧支循环 血管生长、血管生成并改善冠状动脉疾病和 PAD 动物模型的灌注， 在这两种疾病过程中都有有希望的早期人类数据。 Vibrato Medical 利用首款可穿戴治疗超声 (TUS) 设备开发了一种新颖的治疗方法 用于 PAD 的非侵入性门诊治疗，促进侧支血管生长和血管生成， 我们已经证明了 VibratoSleeve 的功效。 使用多种灌注措施显着改善健康志愿者的下肢灌注。 I 期 SBIR 提案的目标是进行一项前瞻性开放标签临床试验，旨在评估 缺血性或神经缺血性 DFU 的灌注急剧改善 总共 12 名受试者将接受治疗。 可穿戴式 VibratoSleeve 对小腿后侧进行 90 分钟的治疗，在 3 次单独的诊所就诊，以低、 中和高声强度设置的效果将通过比较基线和实时进行评估。 治疗，并且每个终点的平均改善将在所有 3 个强度之间进行比较，以确定 我们还将系统地获取患者对易用性、耐受性、 使用每 90 分钟后进行的标准化调查问卷来评估 VibratoSleeve 的舒适度 触觉和舒适度数据将为最佳声学参数、治疗提供信息。 用于评估 DFU 的长期 TUS 治疗后续假对照临床试验的持续时间和设计 康复。