NCT06952543 · Mayo Clinic
Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease
What this study is 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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Ultrasound Imaging
Non-invasive ultrasound will be performed using Angio Flow Reactivity Analysis (AFRA) The ultrasound probe will be attached to the subject's calf muscle and a pressure cuff will be secured around thigh. Ultrasound data will be collected for 1 minute. The cuff will then be induced to a tolerable pressure of no more than 160 mm Hg, and ultrasound data will be collected for 3 minutes while cuff is inflated. The cuff pressure will be released, and ultrasound data will be collected for 2 minutes after the release. Subject will be asked to perform 1 minute plantar flexion exercise, and ultrasound data will be collected for two minutes after the completion of exercise
Primary outcome measures
Detection of peripheral arterial disease using ultrasound perfusion estimation
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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.
Where
- Rochester, Minnesota
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations