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Patients with PAD and ABI 0.4-0.6 for Peripheral Arterial Disease

Phase 2
Waitlist Available
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minutes
Awards & highlights

Study Summary

The measurement of limb skeletal muscle perfusion and perfusion reserve during exercise is an approach that can assess the total impact of the complex pathophysiologic processes in patients with limb ischemia, particularly in those with diabetes in whom distal arterial disease and abnormal microvascular functional responses are common. This trial is designed to: (a) optimize methods for assessment of limb perfusion at rest and during stress using contrast-enhanced ultrasound (normal subjects) and a microbubble contrast agent that is able to provide non-linear signal without destruction at medium acoustic pressures, and (b) to test whether perfusion imaging provides incremental information on the severity of disease in patients with peripheral artery disease.

Eligible Conditions
  • Peripheral Arterial Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Skeletal muscle perfusion as measured by contrast ultrasound with Sonazoid microbubbles

Trial Design

3Treatment groups
Experimental Treatment
Group I: Patients with PAD and ABI 0.4-0.6Experimental Treatment1 Intervention
Intervention: administration of ultrasound contrast agent (drug) to assess muscle perfusion. Patients with moderate to severe PAD (ABI 0.4 to 0.6) will be evaluated with contrast ultrasound perfusion imaging using methods optimized in the first Arm to determine whether symptoms better correlate with perfusion imaging than other measures of PAD severity.
Group II: Patients with PAD Undergoing RevascularizationExperimental Treatment1 Intervention
Intervention: administration of ultrasound contrast agent (drug) to assess change in muscle perfusion produced by revascularization (surgical or percutaneous procedure). Patients with symptomatic PAD will be evaluated with contrast ultrasound perfusion imaging using methods optimized in the first Arm before and within 1 month of revascularization to determine whether improvement in symptoms correlate with perfusion imaging data.
Group III: Healthy subjectsExperimental Treatment1 Intervention
Intervention: administration of ultrasound contrast agent (drug) to assess muscle perfusion. Normal healthy subjects (n=10) will be used for optimization of dose and acoustic settings for performing real-time contrast ultrasound perfusion imaging of the limb.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
974 Previous Clinical Trials
7,385,857 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
894 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid
Jonathan R. Lindner, MD 2016. "Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02398266.
~6 spots leftby Apr 2025
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