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Evaluation of Musculoskeletal Microcirculation With Ultrasound (EMMU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02086331
First Posted: March 13, 2014
Last Update Posted: November 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Imperial College London
January 9, 2014
March 13, 2014
November 21, 2016
December 2013
December 2015   (Final data collection date for primary outcome measure)
Change in microcirculation [ Time Frame: 20 mins on a treadmill (2% gradient) ]
Change in microcirculation (DCEUS ultrasound gastrocnemius and tibialis anterior) between baseline and post-exercise. )
Same as current
Complete list of historical versions of study NCT02086331 on ClinicalTrials.gov Archive Site
Intra-group differences [ Time Frame: 20 minutes on a treadmill( 2% gradient) ]
Differences in mean microcirculation values between groups (baseline to post-exercise)
Same as current
Not Provided
Not Provided
 
Evaluation of Musculoskeletal Microcirculation With Ultrasound
Evaluation of Musculoskeletal Microcirculation With Ultrasound
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.
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Standardised Claudication Treadmill Test
  • 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
  • Active Comparator: Healthy
    Healthy volunteers, deemed to have normal metabolic and cardiovascular biology by trial criteria
    Interventions:
    • Procedure: Contrast enhanced ultrasound
    • Behavioral: Treadmill test
    • Procedure: Contrast enhanced ultrasound
  • Active Comparator: PAD
    Symptomatic peripheral arterial disease
    Interventions:
    • Procedure: Contrast enhanced ultrasound
    • Behavioral: Treadmill test
    • Procedure: Contrast enhanced ultrasound
  • Active Comparator: DM
    Symptomatic diabetic peripheral neuropathy
    Interventions:
    • Procedure: Contrast enhanced ultrasound
    • Behavioral: Treadmill test
    • Procedure: Contrast enhanced ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
December 2015
December 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT02086331
13/LO/0943
13HH0684 ( Other Identifier: Imperial College London )
Yes
Not Provided
Not Provided
Imperial College London
Imperial College London
Not Provided
Principal Investigator: Prof AH Davies Imperial College London
Imperial College London
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP