Recruiting

Ultrasound Cavitation

Sponsor:

University of Virginia

Code:

NCT05749250

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acoustic cavitation of ultrasound enhancing agents

Study Details

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 ID

NCT05749250

Start date

Jan 1, 2023

Status verified date

Feb, 2023

Completion date

Jun 28, 2025

Anticipated

Primary completion date

Feb 28, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cavitation therapy

Subjects treated with cavitation energy

no intervention: Control

Control subjects not treated with cavitation energy

Interventions

Acoustic cavitation of ultrasound enhancing agents

Cavitation therapy

Primary outcome measure

  • Wound dimensions [ Time Frame: 18 days ]

Central Contacts and Locations

Central contacts

Jonathan Lindner, MD

434 297-9442jlindner@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Jonathan Lindner, MD

434-297-9442jlindner@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Mar 1, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2023-03-01.