Ultrasound Cavitation Therapy for CLI
Peripheral Arterial Disease
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility 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.
Sites / Locations
- University of VirginiaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Cavitation therapy
Control
Subjects treated with cavitation energy
Control subjects not treated with cavitation energy