Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD)

Study Overview
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Brief Summary
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This study is evaluating whether a therapeutic ultrasound device can improve symptoms in the leg of peripheral arterial disease (PAD) patients 65 years of age and over.

Detailed Description
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The VibratoSleeve TUS will be used on to assess its acute vasodilatory and perfusion effects in subjects with early stage PAD. Each subject will receive TUS treatment multiple sessions. All post- treatment acute assessments will take place immediately following each day's treatment and no follow-up assessments will be required in this study.

Official Title
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A Prospective, Non-significant Risk, Feasibility Study to Evaluate Serial Applications of VibratoSleeve Therapy to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD) Subjects 65 Years of Age and Older

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: VibratoSleeve Therapeutic Ultrasound Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 65 Diagnosis of PAD. Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator. Exclusion Criteria: Prior stenting in posterior tibial artery. Re-vascularization procedure within 30 days prior to enrollment in the study. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf). History or diagnosis of severe chronic venous insufficiency. Acute limb ischemia within 30 days prior to treatment. History or diagnosis of deep venous thrombosis below the knee in treatment leg. Any conditions that, in the opinion of the investigator, may render the subject unable to complete the study or lead to difficulties for subject compliance with study requirements, or could confound study data. Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period. stenting in posterior tibial artery.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single arm, open-label, feasibility acute phase study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TUS Therapy<br>These subjects will undergo treatments with the Vibrato Sleeve TUS device. | Device: VibratoSleeve Therapeutic Ultrasound Device<br>* The VibratoSleeve is compromised of a 16-transducer array that is mounted within a wrap that conforms to the posterior calf<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean acute flow rate difference during TUS treatment sessions | Quantify perfusion rate | Through study completion, an average of 1 month | 
| Tissue oxygen saturation (StO2) | Assess oxygenation | Through study completion, an average of 1 month | 
| Ankle Brachial Index | Ankle brachial indices to assess the difference in blood pressure in the upper arm and lower limbs | Through study completion, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoint | Device and procedure related adverse events | Through study completion, an average of 1 month | 

 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)