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Augmentation of Limb Perfusion With Contrast Ultrasound

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Our laboratory has discovered that ultrasound (US) imaging together with clinically approved microbubble ultrasound contrast agents can augment limb tissue perfusion. These observations have been made in mice with and without peripheral artery disease (PAD), and also in humans where high power contrast enhanced ultrasound (CEU) was used to measure perfusion but was found also to augment perfusion by almost 2-fold. The latter human studies were performed with ultrasound protocols designed for perfusion imaging and not for flow augmentation. In this study, we will measure the degree to which limb perfusion is augmented with specific therapeutic CEU settings that are still within the FDA-approved limits with regards to US power and contrast dosing.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 99
Healthy Volunteers: t
View:

• Age ≥18 y.o.

• For PAD subjects: known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index or angiography and a Rutherford symptom class of 4-6.

Locations
United States
Oregon
OHSU
RECRUITING
Portland
Contact Information
Primary
Jonathan R Lindner, MD
lindnerj@ohsu.edu
5034943574
Time Frame
Start Date: 2018-06-18
Estimated Completion Date: 2019-12
Participants
Target number of participants: 30
Treatments
Experimental: Healthy subjects
Low-power contrast ultrasound perfusion imaging and measurement of ABI and TBI will be performed before and after a 15 min high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles.
Experimental: Peripheral Artery Disease
Low-power contrast ultrasound perfusion imaging and measurement of ABI and TBI will be performed before and after a 15 min high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles.
Sponsors
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov