Ultrasound Perfusion Measurement for Peripheral Artery Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Gangrene, Lower leg amputation, Ulcer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

87 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the potential of ultrasound perfusion imaging technique for assessing the progression of peripheral arterial disease (PAD) and monitoring its response to therapy by measuring changes in microvessel alterations and perfusion variations.

Research Team

Azra Alizad, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.

I have leg pain when walking and might have peripheral arterial disease.

Exclusion Criteria

People who are considered at higher risk.

I have had an amputation below the knee.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Detection and Assessment

Quantify perfusion of calf muscle in patients with lower leg claudication and compare results to healthy individuals

4 years

Treatment Response Monitoring

Quantify perfusion of calf muscle in PAD patients at 3 time points, 6 months, and every year after treatment

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Ultrasound

Trial Overview 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.

Participant Groups

Group I: Healthy volunteers Experimental Treatment 1 Intervention

A group of healthy volunteers ages 18 and above with no history of smoking, cardiovascular, diabetes or surgery on legs.

Group II: Early detection of PAD, assessment of the disease progression and treatment response Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+