Using ultrasound therapy to treat severe leg ulcers from poor blood flow

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of ultrasound exposure to microbubble contrast agents to treat patients suffering from severe non-healing ulcers due to peripheral arterial disease (PAD). The primary goal is to determine if this ultrasound cavitation can accelerate wound healing and improve tissue perfusion in the affected limb. Participants will undergo treatment involving acoustic cavitation at the wound site and inflow artery, with outcomes measured through ultrasound imaging techniques.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Study coordinator: Jonathan Lindner, MD
• Email: jlindner@virginia.edu
• Phone: 434 297-9442

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.