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Ultrasound Perfusion Measurement for Peripheral Artery Disease

N/A

Waitlist Available

Led By Azra Alizad, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patients with lower leg amputation

Having ulcer and any health condition that does not allow proper use of ultrasound scanning

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether ultrasound can show if a treatment for peripheral artery disease is working by measuring changes in the microvessels and perfusion.

Who is the study for?

This trial is for men and women over 18 who have symptoms of claudication, which often indicates peripheral arterial disease (PAD), and are scheduled for vascular testing. It's not suitable for patients with gangrene, lower leg amputations, ulcers, or conditions that prevent ultrasound use. Vulnerable populations are also excluded.

What is being tested?

The study is exploring the effectiveness of an ultrasound technique to track how PAD progresses and responds to treatment by looking at changes in tiny blood vessels and blood flow.

What are the potential side effects?

Since this trial involves non-invasive ultrasound imaging, there are minimal side effects expected. However, some individuals might experience discomfort during the procedure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an amputation below the knee.

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I have an ulcer or a condition that prevents ultrasound use.

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I have gangrene.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aim 1: Determine the efficacy of ultrasonic perfusion imaging for early detection of PAD. The goal is to quantify the perfusion of cuff muscle in patients with lower leg claudication and compare the results to those obtained in healthy individuals

Secondary study objectives

Aim 2: Determine the efficacy of ultrasonic perfusion imaging for assessment of treatment response in PAD patients. The goal is to quantify the perfusion of the cuff muscle in PAD patients in 3 time points, 6 months, and every year after treatment.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Early detection of PAD, assessment of the disease progression and treatment responseExperimental Treatment1 Intervention

The objective of this arm of the study is to evaluate the potentials of Ultrasound Perfusion imaging technique for early detection of peripheral arterial disease in patients and assess the disease progression and monitor the treatment response. The investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative perfusion estimation of calf muscle that would separate PAD from non-PAD and help early detection of PAD and would help monitoring the disease progression and treatment response.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ultrasound

2013

Completed Phase 1

~4090

0 / 3Eligibility criteria met