RecruitingNot ApplicableNCT06952543

Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease

Ultrasound Perfusion Estimation for Assessment of PAD


Sponsor

Mayo Clinic

Enrollment

400 participants

Start Date

Mar 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

  • 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 Criteria11

  • 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.

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Interventions

DIAGNOSTIC_TESTUltrasound 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


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06952543


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