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Feasibility Study to Evaluate Therapeutic Ultrasound (TUS) to Acutely Increase the Perfusion in Peripheral Arterial Disease (PAD) | Clinical Trials | Clareo Health

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

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

NCT05888740•Vibrato Medical, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Age ≥ 65
•2. Diagnosis of PAD.
•3. Claudication symptoms in Rutherford class 1,2, or 3 as determined by the investigator.

Exclusion Criteria

•1. Prior stenting in posterior tibial artery.
•2. Re-vascularization procedure within 30 days prior to enrollment in the study.
•3. Ulcers, cellulitis, or skin breakdown in treatment areas (posterior calf).
•4. History or diagnosis of severe chronic venous insufficiency.
•5. Acute limb ischemia within 30 days prior to treatment.
•6. History or diagnosis of deep venous thrombosis below the knee in treatment leg.
•7. 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.
•8. Subject's enrollment in another investigational study that has not completed the required primary endpoint follow-up period.
•stenting in posterior tibial artery.

Locations (1)

Vascular & Interventional Specialists of Orange County

Orange, California, United States

Key Dates

Start Date

February 22, 2023

Primary Completion Date

October 10, 2024

Completion Date

October 10, 2024

Last Updated

July 2, 2025

Enrollment

ACTUAL participants

Conditions

Peripheral Arterial Disease

Interventions

VibratoSleeve Therapeutic Ultrasound Device

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

NCT07472049

Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

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RECRUITING

Advanta VXT and Flixene PMCF Registry

NCT07161583

Peripheral Arterial Disease

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

VITUS Post-Market Registry

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