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.

项目摘要 糖尿病（DM）是常见状况（在美国为34m）。大约7个DM患者中有1例患有糖尿病 脚溃疡（DFU）。大约一半的DFU患者患有外周动脉疾病（PAD）， 导致美国250万例缺血性或神经病毒DFU的患者患病率。 DFU的患者 经历复发性住院，慢性伤口愈合问题以及最终严重截肢 限制生活质量和生产力，并将大量的护理烧毁给家庭，以及相当大的成本 医疗保健系统。 DFU的患者经历了一些骨骼去除（750k至13.5m）或 每年截肢（170k），为治疗这些患者提供必要的新选择并防止昂贵 截肢和住院。 DFU的患者也有垫子经历这些症状 由于血液流量不佳，在较大的动脉中均输送血向低腿和较小的动脉 船只分支出来以供应下腿和脚的肌肉和组织。 声学能量模态（例如治疗超声（TUS））已被证明可以促进抵押品 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， 在两个疾病过程中有望早期人类数据。 Vibrato Medical已开发出一种新型治疗方法 对于无创的，门诊治疗PAD，将促进附带血管生长和血管生成， 恢复灌注并降低截肢率。我们已经证明了Vibratosleeve的效率 使用多种灌注测量值明显改善健康志愿者的下肢灌注。 I阶段I SBIR提案的目标是进行一项旨在评估的前瞻性开放标签临床试验 缺血性或神经缺血性DFU的急性改善。共有12名受试者将收到 可穿戴的颤音螺旋体治疗后犊牛在3个单独的诊所下进行90分钟，低点 中和高声强度设置。将通过比较基线和上的疗效来评估功效 将在所有3个强度中比较每个端点的治疗和平均改进，以确定 剂量反应关系。我们还将系统地获得有关易用性，耐受性的反馈， 每90分钟后使用标准化的问卷调查，并舒适地使用颤音 治疗。有关触觉和舒适感的数据将为最佳声学参数提供信息 长期TUS治疗的随后的假手术临床试验的持续时间和设计，以评估DFU 康复。