| NCT ID | NCT05749250 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Virginia |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-01-01 with a primary completion date of 2025-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05749250 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05749250 currently recruiting?
Yes, NCT05749250 is actively recruiting participants. Contact the research team at jlindner@virginia.edu for enrollment information.
Where is the NCT05749250 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT05749250 clinical trial?
NCT05749250 is sponsored by University of Virginia. The trial plans to enroll 30 participants.