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

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Device: VibratoSleeve Therapeutic Ultrasound Device

• 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
• Status Verified: 2023-05
• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Last Update Submitted: 2023-05-24
• Study First Posted: 2023-06-05
• Last Update Posted: 2023-06-05
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• 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

Arm && Interventions

Group	Intervention	Description
TUS Therapy	VibratoSleeve Therapeutic Ultrasound Device	These subjects will undergo treatments with the Vibrato Sleeve TUS device.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety Endpoint	Through study completion, an average of 1 month	Device and procedure related adverse events

Trial Locations

Locations (1)

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