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Completed

NCT Number: NCT04755335

Ultrasonic Perfusion Estimation in Calf Muscle

The purpose of this study is to evaluate the potential of ultrasound perfusion imaging technique for assessing the progression of peripheral arterial disease (PAD) and monitoring its response to therapy by measuring changes in microvessel alterations and perfusion variations.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Ischemia Muscle Cramp Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

The clinical manifestations of peripheral arterial disease (PAD), regardless of etiology, are due to a lack of blood flow to the musculature relative to its metabolism, which results in pain in the affected muscle groups. PAD affecting the lower extremities causes claudication, cramping pain in the calf muscle, thigh or hip muscle induced by exercise. The initial test for evaluation of patients with claudication is ankle brachial index (ABI).

Therefore, a non-invasive and affordable US technique that can quantify blood perfusion and microvasculature density, without using contrast agent, will improve PAD detection in early stage and can monitor the disease progress as well as the treatment response. The investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative imaging of perfusion that would help separating PAD from non-PAD and monitor the disease progression and treatment response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female volunteers > 18 years old.
  • Male and female volunteers with symptom of claudication and suspected peripheral arterial disease (PAD) who are scheduled for vascular testing.

Exclusion criteria

  • Patients with gangrene.
  • Patients with lower leg amputation.
  • Having ulcer and any health condition that does not allow proper use of ultrasound scanning.
  • People considered in "vulnerable" populations.

Treatment and study plan

Ultrasound

Diagnostic Test

In this project, The investigators will use Alpinion ECUBE-12R (Alpinion, Bothell, WA) US platform. This state-of-the-art research US machine provides beam formed as well as Plane-Wave imaging options that allow high frame rate imaging. The investigators have characterized the acoustic output of this system for safe human studies and obtained the IRB approval for human studies. It should be noted that our technique is not limited to the Alpinion system; the investigators can also use other US systems, such as Verasonics, Vantage, (Redmond, WA). This technique can be adapted to other modern US machines in the future.

Primary outcomes

  1. Aim 1: Determine the efficacy of ultrasonic perfusion imaging for early detection of PAD. The goal is to quantify the perfusion of cuff muscle in patients with lower leg claudication and compare the results to those obtained in healthy individuals

    Time frame: 4 yeas

    Perfusion density of the cuff muscle will be quantified by the new automatic ultrasound microvessel quantification technique and the resulting measurements will measure the outcome of this part of the study.

Secondary outcomes

  1. Aim 2: Determine the efficacy of ultrasonic perfusion imaging for assessment of treatment response in PAD patients. The goal is to quantify the perfusion of the cuff muscle in PAD patients in 3 time points, 6 months, and every year after treatment.

    Time frame: 5 years

    At each time point after the treatment, the perfusion density of the cuff muscle will be quantified by the new automatic ultrasound microvessel quantification technique and the resulting measurements will measure the outcome of this part of the study.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Ultrasonic Perfusion Imaging of Peripheral Vascular Disease

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2021
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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