Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT06952543
• Lead Sponsor: Mayo Clinic

Brief Summary

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 monitoring the disease progression and the response to interventional treatment in PAD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-14
• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01
• Primary Completion: 2029-05-30
• Study Completion: 2029-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Patient volunteers:

• Male and Female, ages 18 years old and up
• Symptom of claudication and suspected for PAD
• Scheduled for vascular testing.

Healthy volunteers:

• Male and female, ages 18-75 years old and up
• Normal BMI
• No history of smoking, cardiovascular disease, or diabetes.

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.

Healthy volunteers:

• Include volunteers with BMI not more than 30
• No history of smoking
• No history of (diabetes, hypertension, cardiovascular diseases)
• People considered in "vulnerable" populations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Detection of peripheral arterial disease using ultrasound perfusion estimation	Up to 4 years	Evaluate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ultrasound perfusion estimation compared to a reference standard (e.g., ankle-brachial index \[ABI\], CT angiography, or MR angiography) in diagnosing PAD.

Secondary Outcome Measures

Name	Time	Method
Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation	Up to 4 years	To assess longitudinal changes in perfusion values measured via ultrasound following medical, endovascular, or surgical interventions for PAD.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States