RECRUITING

Ultrasound Cavitation Therapy for CLI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia

Quick Facts

Study Start:2023-01-01
Study Completion:2025-06-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05749250

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index (\<0.9) or non-compressible vessels
  2. * Diagnosis of CLI (Rutherford class IV-VI), and a non-healing ischemic ulcer defined as no change in the prior 3 months.
  1. * Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \[NYHA class IV\]).
  2. * Pregnant or lactating females
  3. * Hypersensitivity to any ultrasound contrast agent or to polyethylene glycol (PEG, macrogol).
  4. * Hemodynamic instability (hypotension with systolic BP \<90 mm Hg, need for vasopressors).
  5. * Expected amputation or revascularization procedure within the ensuing 1 month.

Contacts and Locations

Study Contact

Jonathan Lindner, MD
CONTACT
434 297-9442
jlindner@virginia.edu

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01
Study Completion Date2025-06-28

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2025-06-28

Terms related to this study

Additional Relevant MeSH Terms

  • Peripheral Arterial Disease