Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease

Ultrasound Perfusion Estimation for Assessment of PAD

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Diagnostic test: Ultrasound Imaging

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Azra Alizad, MD; Phone Number: 507-538-1727; Email: alizad.azra@mayo.edu
      • Contact: Fatima Zohra, MS; Phone Number: 5075382234; Email: Zohra.Fatima@mayo.edu
      • Principal Investigator: Azra Alizad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Symptomatic patients with claudication, at risk for peripheral arterial disease (PAD)	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
Experimental: Healthy Volunteers; Healthy volunteers with normal ankle-brachial index (ABI)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of peripheral arterial disease using ultrasound perfusion estimation	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.	Up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation	To assess longitudinal changes in perfusion values measured via ultrasound following medical, endovascular, or surgical interventions for PAD.	Up to 4 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Azra Alizad, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): August 30, 2029

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): May 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: 24-002802; 1R01HL174785-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No