Evaluation of Musculoskeletal Microcirculation With Ultrasound

Standardised Claudication Treadmill Test Clinical Trial

— EMMU  

Official title:

Evaluation of Musculoskeletal Microcirculation With Ultrasound

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02086331
• Other study ID #: 13/LO/0943
• Secondary ID: 13HH0684
• Status: Terminated
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Intermittent Claudication
• Standardised Claudication Treadmill Test

Intervention

Procedure:
• Contrast enhanced ultrasound
Infusion of microbubbles to enhance blood vessels in the leg for ultrasound

Behavioral:
• Treadmill test
Exposes you to exercise in a controlled environment. We will see if we can detect this change with our new ultrasound protocol

Procedure:
• Contrast enhanced ultrasound

Locations

Country	Name	City	State
United Kingdom	Charing Cross Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Threshold of High to Low Frequency Ratio (Threshold HLFR)	Please see published article for in depth method. This ratio is used to classify a given signal as either microbubble or noise. For a pixel containing a micro vessel, as microbubbles occasionally pass this otherwise dark pixel, its temporal signal is expected to have a higher proportion of lower frequency components than white noise. Consequently, the HLFR of the pixel is expected to be smaller than that of noise. A histogram of normalised HLFR shows two expected peaks (one noise, one bubbles). A threshold (Threshold HLFR) is determined to then separate the two peaks. this is done using a double Gaussian model, and where they intercept is deemed the Threshold HLFR.	Baseline, 20 minutes