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NCT Number: NCT06952543

Ultrasound Perfusion Estimation for Assessment of 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 monitoring the disease progression and the response to interventional treatment in PAD patients.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound imaging

Diagnostic Test

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 outcomes

  1. 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.

Secondary outcomes

  1. Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation

    Time frame: Up to 4 years

    To assess longitudinal changes in perfusion values measured via ultrasound following medical, endovascular, or surgical interventions for PAD.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Ultrasound Perfusion Estimation for Assessment of PAD

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 1, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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