Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease

Mayo Clinic

Status: Enrolling

Conditions: Peripheral Arterial Disease

Treatments: Diagnostic Test: Ultrasound Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06952543

1R01HL174785-01 (U.S. NIH Grant/Contract)

24-002802

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

Study Group

Experimental group

Description:

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

Treatment:

Diagnostic Test: Ultrasound Imaging

Healthy Volunteers

Experimental group

Description:

Healthy volunteers with normal ankle-brachial index (ABI)

Treatment:

Diagnostic Test: Ultrasound Imaging