Evaluation of Musculoskeletal Microcirculation With Ultrasound (EMMU)

Imperial College London

Status: Terminated

Conditions: Standardised Claudication Treadmill Test

Treatments: Procedure: Contrast enhanced ultrasound; Behavioral: Treadmill test

Study type: Interventional

Funder types: Other

Identifiers

NCT02086331

13HH0684 (Other Identifier)

13/LO/0943

Details and patient eligibility

About

This study aims to validate the use of Dynamic Contrast-Enhanced Ultrasound in measuring the blood supply to the muscles of the leg, and how this changes with exercise and vascular pathology.

Full description

We propose a model for the use of Dynamic Contrast-Enhanced Ultrasound (DCEU) to directly evaluate the microcirculation of the musculoskeletal system. We believe that this will be a valuable research tool into diseases of the microcirculation, and in the future may also offer a clinical benefit by quantifying and monitoring disease over time and after intervention. It may also allow targeting of therapies towards those patients most at risk of ulcers and peripheral neuropathy, and those that would get the maximum benefit from these therapies.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Group 1 - Healthy subjects Inclusion

• 18+ years old

Exclusion

• Personal history of diabetes or peripheral arterial disease, current pregnancy, previous surgery to the lower limb, heart attack within 4 weeks, or unstable angina

Group 2 - Peripheral arterial disease subjects Inclusion

• 18+ years old, radiological evidence of peripheral arterial disease (arterial doppler or angiogram), ankle-brachial pressure index (ABPI) 0.5-0.8

Exclusion

• Personal history of diabetes, current pregnancy, previous amputation, heart attack within 4 weeks, or unstable angina

Group 3 - Diabetic subjects Inclusion

• 18+ years old, with a clinical diagnoses of diabetes (1, 2)

Exclusion

• ABPI<0.9, previous amputation, current pregnancy or breastfeeding, heart attack within 4 weeks, or unstable angina.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 3 patient groups

Healthy

Active Comparator group

Description:

Healthy volunteers, deemed to have normal metabolic and cardiovascular biology by trial criteria

Treatment:

Procedure: Contrast enhanced ultrasound

Behavioral: Treadmill test

Procedure: Contrast enhanced ultrasound

PAD

Active Comparator group

Description:

Symptomatic peripheral arterial disease

Treatment:

Procedure: Contrast enhanced ultrasound

Behavioral: Treadmill test

Procedure: Contrast enhanced ultrasound

DM

Active Comparator group

Description:

Symptomatic diabetic peripheral neuropathy

Treatment:

Procedure: Contrast enhanced ultrasound

Behavioral: Treadmill test

Procedure: Contrast enhanced ultrasound