Ultrasound Imaging for Peripheral Arterial Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Gangrene, Surgery, Ulcer, Vulnerable, others

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

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to diagnose and monitor Peripheral Arterial Disease (PAD) using ultrasound technology, specifically through Ultrasound Perfusion Estimation. The goal is to develop a non-invasive tool for early detection of PAD and to track treatment effectiveness. The study includes two groups: one with individuals experiencing symptoms like leg pain when walking (claudication) who may have PAD, and another with healthy volunteers. It suits those who experience leg pain during exercise or walking and are scheduled for vascular testing, as well as healthy individuals without a history of smoking or heart problems. As an unphased trial, this study allows participants to contribute to innovative research that could improve early detection and monitoring of PAD.

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 method is safe for diagnosing Peripheral Arterial Disease?

Research shows that using ultrasound to measure blood flow in people with Peripheral Arterial Disease (PAD) is safe and well-tolerated. A previous study found that this method did not cause serious side effects and even improved blood flow and oxygen levels in tissues. As a noninvasive study, it involves no needles or surgeries, enhancing its safety. For those considering joining this trial, the available evidence suggests the procedure is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ultrasound perfusion estimation for peripheral arterial disease (PAD) because it offers a non-invasive way to assess blood flow in the limbs, potentially catching problems earlier than traditional methods like angiography or ankle-brachial index (ABI) measurements. Unlike existing treatments that focus on managing symptoms or opening blocked arteries, this technique uses ultrasound imaging to estimate how well blood is circulating in real-time. This could lead to earlier intervention and more personalized treatment plans for patients with PAD, making it a promising development in vascular health.

What evidence suggests that this ultrasound method is effective for diagnosing Peripheral Arterial Disease?

Research has shown that using ultrasound to estimate blood flow offers a promising method for diagnosing Peripheral Arterial Disease (PAD). This trial will assess the effectiveness of ultrasound perfusion estimation in two groups: symptomatic patients with claudication at risk for PAD and healthy volunteers with a normal ankle-brachial index (ABI). Studies have found that noninvasive ultrasound methods enhance the measurement of blood flow in individuals with PAD. For example, one study found that therapeutic ultrasound increased blood flow by 180% during treatment. Another study introduced a new ultrasound technique that measures blood flow without contrast agents, making it safer and easier. These findings suggest that ultrasound could effectively monitor and manage PAD. ^{1 2 5 6 7}

Who Is on the Research Team?

Azra Alizad

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who may have Peripheral Arterial Disease (PAD), a condition affecting blood flow in the arteries, particularly in the legs. The study aims to include those who could benefit from early diagnosis and monitoring of PAD.

Inclusion Criteria

I am 18-75, have a normal weight, never smoked, and don't have heart disease or diabetes.

I am 18 or older with leg pain during walking, suspected of having PAD, and scheduled for a vascular test.

Exclusion Criteria

Patient volunteers: Patients with gangrene, patients having surgery or stent, patients with ulcer on their leg, any health condition that does not allow proper use of ultrasound scanning, people considered in 'vulnerable' populations.

I am a healthy volunteer with a BMI under 30, no smoking or major health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment using ultrasound perfusion estimation to diagnose PAD

1-2 weeks

Monitoring

Participants are monitored for disease progression and response to interventional treatment using ultrasound perfusion estimation

Up to 4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound Perfusion Estimation

Trial Overview The trial is testing a new noninvasive ultrasound imaging technique designed to diagnose PAD more effectively and monitor disease progression as well as response to treatments.

How Is the Trial Designed?

Group I: Study Group Experimental Treatment 1 Intervention

Symptomatic patients with claudication, at risk for peripheral arterial disease (PAD)

Group II: Healthy Volunteers Experimental Treatment 1 Intervention

Healthy volunteers with normal ankle-brachial index (ABI)

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06952543

Ultrasound Perfusion Estimation for Assessment of ... The purpose of this study is to develop a new noninvasive tool for early diagnosis of Peripheral Arterial Disease (PAD) and use the proposed method for ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39711204/

Noninvasive therapeutic ultrasound to increase perfusion ... Results: Eleven out of 12 enrolled patients completed the study. During 90-minute TUS sessions pedal flow improved by 180% (p < 0.001) on laser ...

3. 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.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0741521423020918

An exercise stress test for contrast-enhanced duplex ... Key Findings: In response to 10 minutes of low-intensity treadmill walking, patients with peripheral arterial disease (PAD) have 39% lower microvascular blood ...

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

Ultrasound Imaging for Peripheral Arterial Disease This N/A medical study run by Mayo Clinic is evaluating whether Ultrasound Perfusion Estimation will have tolerable side effects & efficacy for patients ...

6. trialx.com trialx.com/clinical-trials/listings/321125/ultrasound-perfusion-estimation-for-assessment-of-peripheral-arterial-disease/

Clinical Research Trial Listing ( Peripheral Arterial Disease ... The purpose of this study is to develop a new noninvasive tool for early diagnosis of Peripheral Arterial Disease (PAD) and use the proposed method for ...

7. 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.