Ultrasound Perfusion Estimation for Peripheral Arterial Disease

This study is testing a new way to diagnose and monitor Peripheral Arterial Disease (PAD) using a non-invasive test called Angio Flow Reactivity Analysis (AFRA). This involves attaching an ultrasound probe to your calf and a pressure cuff to your thigh, then collecting ultrasound data for one minute. The main goal is to see if this ultrasound method can accurately detect PAD. Researchers are looking for both people with symptoms of PAD and healthy volunteers. The study aims to enroll 400 participants aged 18 to 75 years old. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 400 participants. It is testing a diagnostic tool rather than a treatment.
What's involved
You would have a non-invasive ultrasound imaging procedure where an ultrasound probe is attached to your calf and a pressure cuff to your thigh. Ultrasound data will be collected for 1 minute.
Compensation
Not stated in the trial record.
Follow-up
The study will assess the detection of peripheral arterial disease using ultrasound perfusion estimation for up to 4 years.

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NCT06952543

Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease

Recruiting
NAAges 18–75InterventionalDiagnostic
Mayo Clinic
~400 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Ultrasound Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detection of peripheral arterial disease using ultrasound perfusion estimation
Measured over Up to 4 years
Peripheral Arterial Disease
1 sites across 1 states
Minnesota1
  • Azra Alizad · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

Male and Female, ages 18 years old and up
Symptom of claudication and suspected for PAD
Scheduled for vascular testing.
Male and female, ages 18-75 years old and up
Normal BMI
No history of smoking, cardiovascular disease, or diabetes.

Exclusion

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.
Include volunteers with BMI not more than 30
No history of smoking
No history of (diabetes, hypertension, cardiovascular diseases)
People considered in "vulnerable" populations.
  • Detection of peripheral arterial disease using ultrasound perfusion estimationUp 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.