Augmentation of Tissue Perfusion in Patients With Peripheral Artery Disease Using Microbubble Cavitation.
O'Neil R Mason, Brian P Davidson, Paul Sheeran...
https://pubmed.ncbi.nlm.nih.gov/31422129/Actively Recruiting
Led by Oregon Health and Science University · Updated on 2018-08-23
30
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating how ultrasound imaging combined with microbubble contrast agents can improve blood flow to the limbs, particularly in people with peripheral artery disease PAD. Previous studies showed that high power contrast-enhanced ultrasound could nearly double limb perfusion, but those studies focused on imaging rather than treatment. This study aims to measure how much limb blood flow can be increased using specific therapeutic ultrasound settings that remain within FDA-approved safety limits. Participants receive a 15-minute high-power ultrasound therapy with intermittent ultrasound bursts and an intravenous infusion of microbubbles. This treatment is followed by low-power contrast ultrasound imaging to measure blood flow changes. The study includes two groups healthy subjects and those with PAD. Measurements such as the ankle-brachial index ABI and toe-brachial index TBI are taken before and after treatment to evaluate perfusion changes. Participants will undergo blood flow assessments at 10 and 60 minutes after the ultrasound therapy to monitor treatment effects. The research team evaluates changes in limb perfusion using ultrasound imaging and clinical measurements. The study is non-randomized and does not involve blinding. Participation involves intravenous microbubble infusion, ultrasound procedures, and clinical assessments to track blood flow improvements over a short period.
CONDITIONS
Augmentation of Limb Perfusion With Contrast Ultrasound
J
Jonathan R Lindner, MD
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Oregon Health and Science University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Contrast ultrasound cavitation | Current standard care for PAD |
|---|---|---|
| What it is | An investigational device approach using ultrasound energy and infused microbubble contrast to enhance limb perfusion through cavitation | Current standard care combining supervised exercise therapy and pharmacotherapy for peripheral artery disease |
| Primary study purpose | To augment limb perfusion in PAD patients and assess blood flow changes at 10 and 60 minutes post-cavitation | To improve walking ability, decrease symptoms, and reduce cardiovascular and limb events with long-term supervised exercise and drugs |
| Evidence status | Early human investigation; proof-of-concept data demonstrate augmented tissue perfusion shortly after intervention | Well-established care with strong evidence for improving walking distance, reducing events, and limb outcomes |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 minutes
Participants receive high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles to augment limb perfusion.
1 treatment visit (in-person)
Duration - Up to 60 minutes after treatment
Participants have blood flow measurements taken before and after the ultrasound therapy to assess changes in limb perfusion.
1 follow-up visit with assessments at 10 and 60 minutes post-therapy
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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O'Neil R Mason, Brian P Davidson, Paul Sheeran...
https://pubmed.ncbi.nlm.nih.gov/31422129/Oregon Health and Science University
Lead Sponsor