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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an ultrasound technique to track changes in blood flow for individuals with peripheral artery disease (PAD), a condition where narrowed arteries reduce blood flow to the limbs. The study aims to detect PAD early and monitor how the condition evolves or responds to treatments. Healthy volunteers and individuals with symptoms like claudication (leg pain when walking) who are scheduled for vascular tests might be suitable candidates. The goal is to develop a reliable, cost-effective method to improve PAD management. As a Phase 2 trial, this research measures the effectiveness of the ultrasound technique in an initial, smaller group, offering participants a chance to contribute to innovative PAD management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ultrasound imaging technique is safe for assessing peripheral artery disease?

Research has shown that ultrasound perfusion imaging is generally safe. As a non-invasive method, it avoids surgery or entering the body, reducing risk compared to other procedures. Although detailed safety data for this specific ultrasound type isn't always available, it is commonly used in labs to assess blood flow. The operator's skill can affect image quality but typically does not impact safety. Overall, ultrasound is a well-tolerated and accessible tool for evaluating conditions like peripheral artery disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to detect and monitor peripheral artery disease (PAD) using ultrasound perfusion imaging. Unlike traditional methods like the ankle-brachial index, which can be invasive or uncomfortable, this technique is non-invasive and potentially more cost-effective. It aims to provide a clear, quantitative estimation of blood flow in the calf muscles, which could help in the early detection of PAD and in tracking how well patients respond to treatment. This innovative approach could revolutionize how PAD is diagnosed and monitored, making it easier and more accessible for patients.

What evidence suggests that this ultrasound imaging technique is effective for assessing peripheral artery disease?

Research has shown that ultrasound imaging is a promising method for checking peripheral artery disease (PAD). In this trial, one arm will focus on the early detection of PAD, assessment of disease progression, and monitoring treatment response using ultrasound perfusion imaging. Studies have found that this technique effectively measures blood flow in the legs, aiding in early detection and monitoring of PAD. For example, using ultrasound without contrast agents has successfully demonstrated blood flow, making it a valuable tool for diagnosing PAD. Additionally, ultrasound can assess blood flow to muscles during exercise, which is crucial for understanding how PAD affects circulation. Overall, ultrasound imaging offers a non-invasive and cost-effective way to track PAD and its response to treatment. ^{4 6 7 8 9}

Who Is on the Research Team?

Azra Alizad, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK570577/

Sonography Vascular Peripheral Arterial Assessment ... - NCBI Duplex ultrasound plays a key role not only in initial diagnosis but also in monitoring disease progression, evaluating treatment effectiveness, ...

2. nature.com nature.com/articles/s41598-023-38576-x

Contrast-free ultrasound imaging for blood flow ... In this study, we present a contrast-free ultrasound-based quantitative blood flow imaging technique for PAD diagnosis.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0301562925001905

Ultrasound and Photoacoustic Imaging of Peripheral Arteries The average success rates for imaging the carotid, common femoral and superficial femoral arteries in healthy volunteers were 75%, 100% and 33.3%, respectively, ...

4. jacc.org jacc.org/doi/10.1016/j.jcmg.2008.04.001

Limb Stress-Rest Perfusion Imaging With Contrast ... Limb microvascular perfusion imaging during exercise, using contrast-enhanced ultrasound can evaluate muscle blood in patients with peripheral arterial disease.

5. academic.oup.com academic.oup.com/eurheartj/article/27/3/310/580318

Contrast ultrasound perfusion imaging of lower extremities in ... It is estimated that ∼15–20% of patients with PAD will progress to critical limb ischaemia, which is associated with a 1-year mortality rate of about 20%.6–8 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10996332/

Perfusion imaging techniques in lower extremity peripheral ... The examination is safe, cheap and accessible in most vascular laboratories. However, like all ultrasound examinations, it is operator-dependent and is limited ...

7. withpower.com withpower.com/trial/phase-peripheral-vascular-diseases-2-2025-4c380

Ultrasound Imaging for Peripheral Arterial Disease Is ultrasound imaging for peripheral arterial disease safe for humans? The research articles reviewed do not provide specific safety data for ultrasound imaging ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071358124007815

New horizons in nuclear cardiology: Imaging of peripheral ... This review provides a comprehensive reassessment of radiotracer-based imaging of PAD in preclinical and clinical studies, emphasizing the challenges that arise ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8772481/

Role of Doppler Ultrasound in Assessing the Severity ... Our study shows that Duplex Doppler sonography aided by color Doppler sonography can accurately locate the site and severity of stenosis/occlusion.