Ultrasound Cavitation Therapy for CLI

University of Virginia30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease

Interventions

Acoustic cavitation of ultrasound enhancing agentsDEVICE

Cavitation therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

Wound dimensions

Area of non-healing ulcer

Time frame: 18 days

Secondary Outcomes

Wound granulation

Area of granulation tissue of the ulcer

Time frame: 18 days

Tissue perfusion

Laser speckle perfusion imaging

Time frame: 18 days

Central Contacts

Jonathan Lindner, MD

CONTACT

434 297-9442 jlindner@virginia.edu

Data from ClinicalTrials.gov

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