A Non-significant Risk Clinical Study to Assess Perfusion Changes With Application of a TUS for Patients With PAD

Study Overview
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Brief Summary
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The objective of the clinical trial is to gather evidence on the safety, performance and clinical efficacy Vibrato Sleeve TUS in people with peripheral artery disease (PAD).

Detailed Description
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Subjects will be randomized to a test or control group and will receive an active or sham Vibrato Sleeve respectively. Those randomized to the control arm will undergo therapy sessions with a sham Vibrato Sleeve device and two months of follow-up. Upon completion of the 2-month follow-up visit, subjects will be informed of their randomization assignment. Subjects in the sham arm will be allowed to crossover to a treatment regimen that uses an active Vibrato Sleeve device and will follow the same visit schedule as the active test group.

Official Title
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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)

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Therapeutic Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥22. Diagnosis of infrapopliteal PAD. Rutherford class 4 or 5 as determined by the investigator. Toe Brachial Index (TBI) ≤ 0.6 OR Toe Blood Pressure ≤ 50 mmHg. Exclusion Criteria: 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 they meet other criteria). 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%. Ongoing hyperbaric oxygen treatment (HBOT) 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. 9. 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).

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective, double-blinded, randomized controlled trial to evaluate the feasibility of TUS in the treatment of PAD.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activated Therapy<br>Therapy: these subjects will undergo 30 treatments with an activated Vibratosleeve TUS device. | Device: Therapeutic Device<br>* This device delivers ultrasound energy to the targeted area of the lower limb.<br>* Other names: VibratoSleeve TUS Device;|
| Sham Comparator: Sham Therapy<br>An inactive (sham) device will be used in these subjects for the first 30 treatments followed by a 30-treatment regimen with an activated VibratoSleeve TUS device after crossover. | Device: Therapeutic Device<br>* This device delivers ultrasound energy to the targeted area of the lower limb.<br>* Other names: VibratoSleeve TUS Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in foot perfusion | Mean difference between pre-treatment (baseline) and/or last sham treatment with post-treatment measurements, including the 2-month follow-up. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Analysis of all reported device-related adverse events throughout each subject's participation. | up to and including the 2-month follow-up visit for test and control subjects. | 
| Subject Questionnaire | Questions will be based on each treatment session and what each subject felt and observed. | up to and including the 2-month follow-up visit for test and control subjects. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic Ultrasound (TUS), Peripheral Artery Disease (PAD), Critical Limb Ischemia (CLI)