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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vibrato Medical, Inc.
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Mean Acute Flow Rate Difference During TUS Treatment Sessions
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Arms & Interventions
TUS Therapy
These subjects will undergo treatments with the Vibrato Sleeve TUS device.
Intervention: VibratoSleeve Therapeutic Ultrasound Device (Device)
Outcomes
Primary Outcomes
Mean Acute Flow Rate Difference During TUS Treatment Sessions
Time Frame: Baseline to end of treatment, an average of 1 month
Percent change in perfusion measured by FlowMet calculated between baseline and after final treatment.
Tissue Oxygen Saturation (StO2)
Time Frame: Through study completion, an average of 1 month
Calculate changes in tissue oxygen saturation (StO2) measured non-invasively by Clarifi spatial frequency domain imaging system, compared from baseline to during and immediately post-treatment.
Ankle Brachial Index (ABI)
Time Frame: Baseline to end of treatment, an average of 1 month
ABI is ratio that compares blood pressure in the arm to blood pressure in the ankle. It is a measurement of the extent of peripheral arterial disease.
Secondary Outcomes
- Incidence of Device and Procedure-related Adverse Events(Through study completion, an average of 1 month)