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Ultrasound Therapy

Ultrasound Cavitation Therapy for Peripheral Arterial Disease

N/A
Recruiting
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index (<0.9) or non-compressible vessels
Be older than 18 years old
Must not have
Expected amputation or revascularization procedure within the ensuing 1 month
Hemodynamic instability (hypotension with systolic BP <90 mm Hg, need for vasopressors)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how ultrasound and microbubble contrast agents can accelerate healing of severe non-healing ulcers caused by PAD. It will measure tissue perfusion changes in the affected limb & wound.

Who is the study for?
This trial is for people with severe non-healing ulcers due to Peripheral Arterial Disease (PAD), specifically those who have not seen any improvement in the past 3 months. Participants must have a confirmed PAD diagnosis and be classified as having Critical Limb Ischemia. Those with major illnesses affecting the limb, pregnant or breastfeeding women, allergies to ultrasound contrast agents or PEG, unstable blood pressure, or upcoming amputation are excluded.
What is being tested?
The study tests if using ultrasound to shake microbubble contrast agents can help heal severe ulcers caused by poor blood flow in PAD patients. It looks at whether this treatment speeds up healing and improves blood flow in the affected limb compared to usual care without these ultrasound effects.
What are the potential side effects?
Potential side effects may include discomfort from the ultrasound procedure itself and possible allergic reactions to the microbubble contrast agent used during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PAD due to low ankle-brachial index or non-compressible vessels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am expected to undergo amputation or a procedure to restore blood flow within the next month.
Select...
I have low blood pressure or need medication to increase my blood pressure.
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I do not have severe illnesses affecting my limbs besides PAD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Wound dimensions
Secondary study objectives
Tissue perfusion
Wound granulation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cavitation therapyExperimental Treatment1 Intervention
Subjects treated with cavitation energy
Group II: ControlActive Control1 Intervention
Control subjects not treated with cavitation energy

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
781 Previous Clinical Trials
1,315,640 Total Patients Enrolled
8 Trials studying Peripheral Arterial Disease
480 Patients Enrolled for Peripheral Arterial Disease

Media Library

Ultrasound Cavitation Therapy (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05749250 — N/A
Peripheral Arterial Disease Research Study Groups: Cavitation therapy, Control
Peripheral Arterial Disease Clinical Trial 2023: Ultrasound Cavitation Therapy Highlights & Side Effects. Trial Name: NCT05749250 — N/A
Ultrasound Cavitation Therapy (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05749250 — N/A
~4 spots leftby Feb 2025
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