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

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT05888740
• Lead Sponsor: Vibrato Medical, Inc.

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 Timeline

• Study Start: 2023-02-22
• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10
• Results First Submitted: 2025-04-15
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Results First Posted: 2025-07-02
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean Acute Flow Rate Difference During TUS Treatment Sessions	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)	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)	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 Outcome Measures

Name	Time	Method
Incidence of Device and Procedure-related Adverse Events	Through study completion, an average of 1 month	Number of adverse events related to the VibratoSleeve device or study procedure occurring throughout the duration of the study.

Trial Locations

Locations (1)

Vascular & Interventional Specialists of Orange County; 🇺🇸 Orange, California, United States