Ultrasound Cavitation Therapy for CLI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acoustic cavitation of ultrasound enhancing agents.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia
Overview
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.
Interventions
- Device Acoustic cavitation of ultrasound enhancing agents
Cavitation therapy
Primary outcome measures
- Wound dimensions [Time frame: 18 days]
Secondary outcome measures (2)
- Wound granulation [Time frame: 18 days]
- Tissue perfusion [Time frame: 18 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Virginia — Charlottesville
Identifiers
NCT: NCT05749250 · HSR220344