Ultrasound Cavitation Therapy for CLI
Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2025
CompletedMarch 1, 2023
February 1, 2023
2.2 years
October 25, 2022
February 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Wound dimensions
Area of non-healing ulcer
18 days
Secondary Outcomes (2)
Wound granulation
18 days
Tissue perfusion
18 days
Study Arms (2)
Cavitation therapy
EXPERIMENTALSubjects treated with cavitation energy
Control
NO INTERVENTIONControl subjects not treated with cavitation energy
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Cardiovascular Medicine
Study Record Dates
First Submitted
October 25, 2022
First Posted
March 1, 2023
Study Start
January 1, 2023
Primary Completion
February 28, 2025
Study Completion
June 28, 2025
Last Updated
March 1, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share