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NCT05749250 Clinical Trial

Ultrasound Cavitation Therapy for CLI

Peripheral Arterial Disease Clinical Trial

Official title:
Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05749250
Other study ID # HSR220344
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date June 28, 2025

Study information
Verified date February 2023
Source University of Virginia
Contact Jonathan Lindner, MD
Phone 434 297-9442
Email jlindner@virginia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, we will explore how ultrasound exposure of ultrasound contrast agents, which produces beneficial shear-mediated bioeffects, can be used to treat patients with severe non-healing ulcers secondary to peripheral arterial disease (PAD). The primary outcome measure is whether ultrasound exposure to microbubble contrast agents in the inflow artery and at the wound site can accelerate wound healing. A secondary outcome measure is whether cavitation-related changes occur in tissue perfusion in the treated limb and wound measured by ultrasound perfusion imaging and skin flow.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index (<0.9) or non-compressible vessels - Diagnosis of CLI (Rutherford class IV-VI), and a non-healing ischemic ulcer defined as no change in the prior 3 months. Exclusion Criteria: - Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure [NYHA class IV]). - Pregnant or lactating females - Hypersensitivity to any ultrasound contrast agent or to polyethylene glycol (PEG, macrogol). - Hemodynamic instability (hypotension with systolic BP <90 mm Hg, need for vasopressors). - Expected amputation or revascularization procedure within the ensuing 1 month.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Acoustic cavitation of ultrasound enhancing agents
Cavitation therapy

Locations
Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)
Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Wound dimensions Area of non-healing ulcer 18 days
Secondary Wound granulation Area of granulation tissue of the ulcer 18 days
Secondary Tissue perfusion Laser speckle perfusion imaging 18 days
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