Ultrasound Cavitation Therapy for CLI

Sponsor

University of Virginia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05749250

Collaborator

(none)

Enrollment

Location

Arms

29.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Device: Acoustic cavitation of ultrasound enhancing agents	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2025

Anticipated Study Completion Date :

Jun 28, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Wound dimensions [18 days]
Area of non-healing ulcer

Secondary Outcome Measures

Wound granulation [18 days]
Area of granulation tissue of the ulcer
Tissue perfusion [18 days]
Laser speckle perfusion imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

University of Virginia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jonathan Lindner, MD, Professor of Medicine, Cardiovascular Medicine, University of Virginia

ClinicalTrials.gov Identifier:

NCT05749250

Other Study ID Numbers:

HSR220344

First Posted:

Mar 1, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Peripheral Arterial Disease

Peripheral Vascular Diseases

Study Results

No Results Posted as of Mar 1, 2023