Recruiting

Peripheral Arterial Disease

Sponsor:

Mayo Clinic

Code:

NCT06952543

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Ultrasound Imaging

Study Details

Brief 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.

Conditions

Peripheral Arterial Disease

Study ID

NCT06952543

Start date

Mar 14, 2025

Status verified date

Apr, 2026

Completion date

Aug 30, 2029

Anticipated

Primary completion date

May 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Study Group

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

experimental: Healthy Volunteers

Healthy volunteers with normal ankle-brachial index (ABI)

Interventions

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 measure

  • Detection of peripheral arterial disease using ultrasound perfusion estimation [ Time Frame: Up to 4 years ]

Central Contacts and Locations

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Azra Alizad, MD

507-538-1727alizad.azra@mayo.edu

Fatima Zohra, MS

5075382234Zohra.Fatima@mayo.edu

Principal Investigator:

Azra Alizad

More Information

Sponsor

Mayo Clinic

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-05-05.