A Non-significant Risk Clinical Study to Assess Changes in Perfusion Resulting From Application of the VibratoSleeve, a Therapeutic Ultrasound (TUS) Phased Array, for Patients With Peripheral Arterial Disease (PAD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in foot perfusion
研究概览
简要总结
All evaluable subjects will receive VibratoSleeve therapeutic ultrasound (TUS) treatments. The device will be programmed to deliver TUS at a pre-determined level. Three different acoustic intensity levels will be tested during the first three treatment visits (one at each visit day). The most effective treatment that is comfortable to a subject will be prescribed for the remaining treatment sessions. Treatment time will be 90 minutes per session, one session per day. Thirty treatment sessions will be performed over a 45-day period.
Subjects will appear for on-site follow-up visits at 1-, 3-, and 6-months following subject's last (30th) treatment session.
详细描述
Screening procedures:
Prospective participants will be recruited for participation and informed consent will be obtained after all information is presented and all questions are answered to the patient's satisfaction. Once informed consent is obtained, the study team will confirm the patient meets all inclusion criteria and no exclusion criteria.
The following is a list of all assessments and tests that are required during the screening visit.
- Medical history, demographics, and Rutherford Class, vital signs, & circumference measurement of one calf.
- Ankle Brachial Index and Toe Brachial Index (ABI/TBI) will be measured at screening to determine eligibility and baseline values.
- Ultrasonography and Perfusion Imaging of the Foot will be undertaken prior to, during and after application of the VibratoSleeve TUS. All patients will undergo arterial duplex ultrasound at the level of the calf, ankle and/or foot to document the baseline vessel diameter, vessel velocity and volume flow. Perfusion imaging of the foot will be completed, using non-invasive methods like Flowmet by Medtronic, Inc. and Clarifi system by Modulim.
Treatments:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
N/R
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of infrapopliteal PAD.
- •Rutherford class 3, 4 or 5 as determined by the investigator.
- •Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg.
排除标准
- •Prior stenting in posterior tibial, anterior tibial or peroneal artery.
- •Re-vascularization procedure within 25 days prior to enrollment in the study. (Note: Patients who had re-vascularization procedure earlier than 25 days prior to enrollment are eligible for enrollment if all other criteria are met).
- •Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
- •History or diagnosis of severe chronic venous insufficiency or mixed arterio-venous disease.
- •Acute limb ischemia within 30 days prior to treatment.
- •History or diagnosis of deep venous thrombosis below the knee in treatment leg.
- •Uncontrolled diabetes defined as HbA1c greater than 10%.
- •Any conditions that, in the opinion of the investigator, may render the patient unable to complete the study or lead to difficulties for patient compliance with study requirements, or could confound study data.
- •Patient's enrollment in another investigational study that has not completed the required primary endpoint follow-up period (Note: Patients involved in a long-term surveillance phase of another study are eligible for enrollment in this study).
- •Eligibility for patients with bi-lateral PAD will be assessed based on the leg that has more advanced PAD. For bi-lateral PAD patients only one leg with the more advanced bi-lateral PAD will be treated.
结局指标
主要结局
Changes in foot perfusion
时间窗: Through study completion, an average of 6 months
(2) Mean difference between pre-treatment (baseline) and post-treatment, and at the 1-, 3-, and 6-months post-treatment follow up visits, using Clarifi Imaging System (Modulim), which uses spatial frequency domain imaging (SFDI), to measure tissue oxygen saturation (StO2) and tissue hemoglobin (Hb) in the dermal microcirculation (HbT1) and macrocirculation (HbT2) to assess lower extremity blood supply.
次要结局
- Subject Questionnaire(Through study completion, an average of 6 months.)
- Adverse Events(Through study completion, an average of 6 months.)