Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-14

Study Completion Date

2029-08-30

Brief Summary

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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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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Group

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

Group Type EXPERIMENTAL

Ultrasound Imaging

Intervention Type 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

Healthy Volunteers

Healthy volunteers with normal ankle-brachial index (ABI)

Group Type EXPERIMENTAL

Ultrasound Imaging

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes