Improving blood flow in limbs using ultrasound
Augmentation of Limb Perfusion With Contrast Ultrasound
NA · Oregon Health and Science University · NCT03195556
This study is testing whether a special ultrasound technique can improve blood flow in the limbs of people with peripheral arterial disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years to 99 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University (other) |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT03195556 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of contrast-enhanced ultrasound (CEU) to enhance limb tissue perfusion in patients with peripheral arterial disease (PAD). The research builds on previous findings that CEU can significantly increase blood flow, and aims to determine the effectiveness of specific ultrasound settings within FDA-approved limits. Participants will undergo ultrasound imaging to measure the degree of perfusion augmentation, providing insights into potential therapeutic applications for PAD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosed history of unilateral or bilateral peripheral arterial disease.
Not a fit: Patients with major medical illnesses affecting limb flow, severe heart failure, or other significant cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve blood flow and quality of life for patients suffering from peripheral arterial disease.
How similar studies have performed: Previous studies have shown promising results with contrast-enhanced ultrasound for perfusion measurement, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: 1. Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \[NYHA class IV or LVEF \<30%\]). 2. Pregnant or lactating females 3. Hypersensitivity to any ultrasound contrast agent 4. Known atrial septal defect or large right to left shunt. 5. Hemodynamic instability (hypotension with systolic BP \<90 mm Hg, need for vasopressors) 6. Evidence for ongoing myocardial ischemia 7. For normal controls, any known structural non-arrhythmic cardiovascular disease (coronary artery disease, heart failure, moderate or greater valve disease).
Where this trial is running
Portland, Oregon
- OHSU — Portland, Oregon, United States (RECRUITING)
Study contacts
- Study coordinator: Jonathan R Lindner, MD
- Email: lindnerj@ohsu.edu
- Phone: 5034943574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Arterial Disease