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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have been diagnosed with PAD due to low ankle-brachial index or non-compressible vessels.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Wound dimensions
Secondary outcome measures
Tissue perfusion
Wound granulation

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
754 Previous Clinical Trials
1,245,043 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an upper limit on the number of participants this experiment can accommodate?

"Affirmative. The clinical trial database hosted on clinicaltrials.gov lists the study as currently being actively enrolled in, with an initial post date of January 1st 2023 and a last update time of February 28th 2023. This medical experiment is expecting 30 participants to be recruited from one location."

Answered by AI

Are there any openings in the current clinical trial?

"Affirmative. Per the data hosted on clinicaltrials.gov, this medical trial is still actively recruiting patients with its first posting dating back to January 1st 2023 and most recent update taking place on February 28th of the same year. A total of 30 participants are needed for this study at a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ultrasound Cavitation Therapy for CLI
Jonathan Lindner, MD 2023. "Ultrasound Cavitation Therapy for CLI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05749250.
All > Pad
~12 spots leftby Feb 2025
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