Evaluation of Musculoskeletal Microcirculation With Ultrasound

Not Applicable

Terminated

• Conditions: Standardised Claudication Treadmill Test
• Interventions: Procedure: Contrast enhanced ultrasound; Behavioral: Treadmill test

• Registration Number: NCT02086331
• Lead Sponsor: Imperial College London

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2020-10-05
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-02
• Last Update Submitted: 2020-11-02
• Results First Posted: 2020-11-25
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DM	Contrast enhanced ultrasound	Symptomatic diabetic peripheral neuropathy
PAD	Contrast enhanced ultrasound	Symptomatic peripheral arterial disease
PAD	Treadmill test	Symptomatic peripheral arterial disease
Healthy	Contrast enhanced ultrasound	Healthy volunteers, deemed to have normal metabolic and cardiovascular biology by trial criteria
Healthy	Treadmill test	Healthy volunteers, deemed to have normal metabolic and cardiovascular biology by trial criteria
DM	Treadmill test	Symptomatic diabetic peripheral neuropathy

Primary Outcome Measures

Name	Time	Method
Threshold of High to Low Frequency Ratio (Threshold HLFR)	Baseline, 20 minutes	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.

Trial Locations

Locations (1)

Charing Cross Hospital; 🇬🇧 London, United Kingdom