Ultrasound Cavitation Therapy for CLI
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cavitation therapy Subjects treated with cavitation energy |
Device: Acoustic cavitation of ultrasound enhancing agents
Cavitation therapy
|
No Intervention: Control Control subjects not treated with cavitation energy |
Outcome Measures
Primary Outcome Measures
- Wound dimensions [18 days]
Area of non-healing ulcer
Secondary Outcome Measures
- Wound granulation [18 days]
Area of granulation tissue of the ulcer
- Tissue perfusion [18 days]
Laser speckle perfusion imaging
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index (<0.9) or non-compressible vessels
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Diagnosis of CLI (Rutherford class IV-VI), and a non-healing ischemic ulcer defined as no change in the prior 3 months.
Exclusion Criteria:
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Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure [NYHA class IV]).
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Pregnant or lactating females
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Hypersensitivity to any ultrasound contrast agent or to polyethylene glycol (PEG, macrogol).
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Hemodynamic instability (hypotension with systolic BP <90 mm Hg, need for vasopressors).
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Expected amputation or revascularization procedure within the ensuing 1 month.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
Sponsors and Collaborators
- University of Virginia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSR220344