Ultrasonic Perfusion Estimation in Calf Muscle

Mayo Clinic

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Diagnostic Test: Ultrasound

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04755335

5R01HL148664-02 (U.S. NIH Grant/Contract)

R01HL148664 (U.S. NIH Grant/Contract)

19-002559

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

87 participants in 2 patient groups

Early detection of PAD, assessment of the disease progression and treatment response

Description:

The objective of this arm of the study is to evaluate the potentials of Ultrasound Perfusion imaging technique for early detection of peripheral arterial disease in patients and assess the disease progression and monitor the treatment response. The investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative perfusion estimation of calf muscle that would separate PAD from non-PAD and help early detection of PAD and would help monitoring the disease progression and treatment response.

Treatment:

Diagnostic Test: Ultrasound

Healthy volunteers

Description:

A group of healthy volunteers ages 18 and above with no history of smoking, cardiovascular, diabetes or surgery on legs.

Treatment:

Diagnostic Test: Ultrasound