Using therapeutic ultrasound to improve blood flow in patients with peripheral arterial disease

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

This study tests whether a special ultrasound device can help improve blood flow and reduce symptoms for older patients with early-stage peripheral arterial disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Vibrato Medical, Inc. (Industry-sponsored)
• Locations: 1 site (Orange, California)
• Trial ID: NCT05888740 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the VibratoSleeve therapeutic ultrasound device in enhancing blood flow and alleviating symptoms in patients aged 65 and older with peripheral arterial disease (PAD). Participants will undergo multiple sessions of ultrasound treatment, with immediate assessments conducted after each session to measure acute effects on vasodilation and perfusion. The study focuses on patients with early-stage PAD and aims to determine the feasibility of this non-invasive treatment approach.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 65 and older diagnosed with peripheral arterial disease and experiencing claudication symptoms.

Not a fit: Patients who have had recent vascular procedures or significant skin issues in the treatment area may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood flow and reduce symptoms for elderly patients suffering from peripheral arterial disease.

How similar studies have performed: While this approach is innovative, similar studies using therapeutic ultrasound for vascular conditions have shown promise, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Orange, California

• Vascular & Interventional Specialists of Orange County — Orange, California, United States (Recruiting)

Study contacts

• Study coordinator: Bisrat Woldemichael

Conditions Peripheral Arterial Disease; Therapeutic Ultrasound; Peripheral Artery Disease; Critical Limb Ischemia