Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease

ConditionPeripheral Arterial Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorMayo Clinic

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Male and Female, ages 18 years old and up

Symptom of claudication and suspected for PAD

Scheduled for vascular testing.

Male and female, ages 18-75 years old and up

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: Study GroupExperimental treatment 1 intervention

Group B: Healthy VolunteersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Up to 4 years

Secondary outcomes

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.

Time frame

Up to 4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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