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Evaluation of Musculoskeletal Microcirculation With Ultrasound (EMMU)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT02086331
First received: January 9, 2014
Last updated: November 18, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Standardised Claudication Treadmill Test
Procedure: Contrast enhanced ultrasound
Behavioral: Treadmill test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Musculoskeletal Microcirculation With Ultrasound

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Change in microcirculation [ Time Frame: 20 mins on a treadmill (2% gradient) ] [ Designated as safety issue: No ]
    Change in microcirculation (DCEUS ultrasound gastrocnemius and tibialis anterior) between baseline and post-exercise. )


Secondary Outcome Measures:
  • Intra-group differences [ Time Frame: 20 minutes on a treadmill( 2% gradient) ] [ Designated as safety issue: No ]
    Differences in mean microcirculation values between groups (baseline to post-exercise)


Enrollment: 5
Study Start Date: December 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy
Healthy volunteers, deemed to have normal metabolic and cardiovascular biology by trial criteria
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: PAD
Symptomatic peripheral arterial disease
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: DM
Symptomatic diabetic peripheral neuropathy
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02086331

Locations
United Kingdom
Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Prof AH Davies Imperial College London
  More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02086331     History of Changes
Other Study ID Numbers: 13/LO/0943  13HH0684 
Study First Received: January 9, 2014
Last Updated: November 18, 2016
Health Authority: United Kingdom: Research Ethics Committee Imperial College London

ClinicalTrials.gov processed this record on December 06, 2016