Ultrasound Cavitation Therapy for CLI

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

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 Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Acoustic cavitation of ultrasound enhancing agents

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Lindner, MD; Phone Number: 434 297-9442; Email: jlindner@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Contact: Jonathan Lindner, MD; Phone Number: 434-297-9442; Email: jlindner@virginia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cavitation therapy; Subjects treated with cavitation energy	Device: Acoustic cavitation of ultrasound enhancing agents; Cavitation therapy
No Intervention: Control; Control subjects not treated with cavitation energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound dimensions	Area of non-healing ulcer	18 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound granulation	Area of granulation tissue of the ulcer	18 days
Tissue perfusion	Laser speckle perfusion imaging	18 days

Collaborators and Investigators

• Sponsor: University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): February 28, 2025
• Study Completion (Anticipated): June 28, 2025

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: HSR220344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes