Ultrasound Cavitation Therapy for CLI

University of Virginia

Status

Enrolling

Conditions

Peripheral Arterial Disease

Treatments

Device: Acoustic cavitation of ultrasound enhancing agents

Study type

Interventional

Funder types

Other

Identifiers

NCT05749250

HSR220344

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.