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NCT Number: NCT05749250

Ultrasound Cavitation Therapy for CLI

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location status: Recruiting

Location contact

Jonathan Lindner, MD

CONTACT

[email protected]

434-297-9442

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acoustic cavitation of ultrasound enhancing agents

Device

Cavitation therapy

Primary outcomes

  1. Wound dimensions

    Time frame: 18 days

    Area of non-healing ulcer

Secondary outcomes

  1. Wound granulation

    Time frame: 18 days

    Area of granulation tissue of the ulcer

  2. Tissue perfusion

    Time frame: 18 days

    Laser speckle perfusion imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Lindner, MD

CONTACT

[email protected]

434 297-9442

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2023
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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