Ultrasound Cavitation Therapy for CLI

Description

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.

Conditions

Peripheral Arterial Disease

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Study Overview

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Study Details

Study 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.

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

Ultrasound Cavitation Therapy for CLI

Condition
Peripheral Arterial Disease
Intervention / Treatment

-

Contacts and Locations

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Virginia,

Study Record Dates

2025-06-28