NCT05749250

Ultrasound Cavitation Therapy for CLI

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Acoustic cavitation of ultrasound enhancing agents	Cavitation therapy

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-02-28
• Completion: 2025-06-28
• First posted: 2023-03-01
• Last updated: 2023-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study