Using ultrasound therapy to treat severe leg ulcers from poor blood flow
Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia
This study is testing if using ultrasound therapy can help heal severe leg ulcers in people with poor blood flow caused by peripheral arterial disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05749250 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of critical limb ischemia and non-healing ischemic ulcers.
Not a fit: Patients with major medical illnesses affecting limb blood flow or those expecting imminent surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve healing rates for patients with chronic ulcers caused by PAD.
How similar studies have performed: While the approach is innovative, similar studies exploring ultrasound therapies for wound healing have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Jonathan Lindner, MD
- Email: jlindner@virginia.edu
- Phone: 434 297-9442
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.