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Ultrasound Cavitation Therapy for CLI

Primary Purpose

Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acoustic cavitation of ultrasound enhancing agents
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cavitation therapy

Control

Arm Description

Subjects treated with cavitation energy

Control subjects not treated with cavitation energy

Outcomes

Primary Outcome Measures

Wound dimensions
Area of non-healing ulcer

Secondary Outcome Measures

Wound granulation
Area of granulation tissue of the ulcer
Tissue perfusion
Laser speckle perfusion imaging

Full Information

First Posted
October 25, 2022
Last Updated
February 28, 2023
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT05749250
Brief Title
Ultrasound Cavitation Therapy for CLI
Official Title
Ultrasound Cavitation for Treatment of Non-healing Ulcers in Critical Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
June 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cavitation therapy
Arm Type
Experimental
Arm Description
Subjects treated with cavitation energy
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control subjects not treated with cavitation energy
Intervention Type
Device
Intervention Name(s)
Acoustic cavitation of ultrasound enhancing agents
Intervention Description
Cavitation therapy
Primary Outcome Measure Information:
Title
Wound dimensions
Description
Area of non-healing ulcer
Time Frame
18 days
Secondary Outcome Measure Information:
Title
Wound granulation
Description
Area of granulation tissue of the ulcer
Time Frame
18 days
Title
Tissue perfusion
Description
Laser speckle perfusion imaging
Time Frame
18 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Lindner, MD
Phone
434 297-9442
Email
jlindner@virginia.edu
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Lindner, MD
Phone
434-297-9442
Email
jlindner@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasound Cavitation Therapy for CLI

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