Ultrasound Cavitation Therapy for CLI

NCT ID: NCT05749250

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-06-28

Brief 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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cavitation therapy

Subjects treated with cavitation energy

Group Type: EXPERIMENTAL

Acoustic cavitation of ultrasound enhancing agents

Intervention Type: DEVICE

Cavitation therapy

Control

Control subjects not treated with cavitation energy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acoustic cavitation of ultrasound enhancing agents

Cavitation therapy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Lindner, MD

Professor of Medicine, Cardiovascular Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonathan Lindner, MD

Role: CONTACT

jlindner@virginia.edu

434 297-9442

Facility Contacts

Jonathan Lindner, MD

Role: primary

jlindner@virginia.edu

434-297-9442

Other Identifiers

HSR220344

Identifier Type: -

Identifier Source: org_study_id