Ultrasound Cavitation Therapy for CLI

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT05749250
Status
Recruiting
Apply to this trial

Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acoustic cavitation of ultrasound enhancing agents — DEVICE
    Cavitation therapy

Study Details

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.

Key Dates

Start date
Jan 1, 2023
Status verified
Feb 2023
Primary completion
Feb 28, 2025
Completion
Jun 28, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cavitation therapy
    Subjects treated with cavitation energy
  • No Intervention: Control
    Control subjects not treated with cavitation energy

Primary Outcome Measure

Wound dimensions [ Time Frame: 18 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Jonathan Lindner, MD
[email protected]
434-297-9442

Find similar trials in Charlottesville, VA

By research site
University of Virginia· Charlottesville, VA

Related Studies