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Ultrasound Cavitation Therapy for Peripheral Arterial Disease

This study is exploring a treatment called ultrasound cavitation therapy for people with severe peripheral arterial disease (PAD) who have non-healing wounds. This therapy uses ultrasound exposure with ultrasound enhancing agents (microbubbles) to try and speed up wound healing. To join, you must be at least 18 years old, have a known history of PAD, and a non-healing wound (Rutherford class IV-VI) that hasn't changed in the last three months. The main goal is to see if this treatment can make wounds heal faster, with wound dimensions measured at 18 days. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome measure for wound healing is taken at 18 days.

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NCT05749250

Ultrasound Cavitation Therapy for CLI

Recruiting
NAAges 18+InterventionalTreatment
University of Virginia
~30 participants
Updated 2023-03-01 on ClinicalTrials.gov
What's tested:Acoustic cavitation of ultrasound enhancing agents

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Wound dimensions
Measured over 18 days

Conditions

Peripheral Arterial Disease

Explore related trials

Peripheral Artery Disease

Where it's being run

1 sites across 1 states
Virginia1

Who to contact

Jonathan Lindner, MD
[email protected]
434 297-9442
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Wound dimensions18 days

    Area of non-healing ulcer