Actively Recruiting
Ultrasound Cavitation Therapy for CLI
Led by University of Virginia · Updated on 2023-03-01
30
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ultrasound Cavitation Therapy for CLI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Known history of unilateral or bilateral peripheral arterial disease diagnosed by reduced ankle-brachial index (<0.9) or non-compressible vessels
- Diagnosis of critical limb ischemia (Rutherford class IV-VI)
- Presence of a non-healing ischemic ulcer with no change in the prior 3 months
You will not qualify if you...
- Major medical illness other than peripheral arterial disease 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 blood pressure <90 mm Hg or need for vasopressors)
- Expected amputation or revascularization procedure within the next 1 month
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
J
Jonathan Lindner, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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