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Evaluation of Musculoskeletal Microcirculation With Ultrasound

NCT ID: NCT02086331

Last Updated: 2020-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Standardised Claudication Treadmill Test

Keywords

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treadmill test

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy

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

Group Type ACTIVE_COMPARATOR

Contrast enhanced ultrasound

Intervention Type PROCEDURE

Infusion of microbubbles to enhance blood vessels in the leg for ultrasound

Treadmill test

Intervention Type BEHAVIORAL

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

Contrast enhanced ultrasound

Intervention Type PROCEDURE

PAD

Symptomatic peripheral arterial disease

Group Type ACTIVE_COMPARATOR

Contrast enhanced ultrasound

Intervention Type PROCEDURE

Infusion of microbubbles to enhance blood vessels in the leg for ultrasound

Treadmill test

Intervention Type BEHAVIORAL

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

Contrast enhanced ultrasound

Intervention Type PROCEDURE

DM

Symptomatic diabetic peripheral neuropathy

Group Type ACTIVE_COMPARATOR

Contrast enhanced ultrasound

Intervention Type PROCEDURE

Infusion of microbubbles to enhance blood vessels in the leg for ultrasound

Treadmill test

Intervention Type BEHAVIORAL

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

Contrast enhanced ultrasound

Intervention Type PROCEDURE

Interventions

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Contrast enhanced ultrasound

Infusion of microbubbles to enhance blood vessels in the leg for ultrasound

Intervention Type PROCEDURE

Treadmill test

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

Intervention Type BEHAVIORAL

Contrast enhanced ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof AH Davies

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Charing Cross Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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13HH0684

Identifier Type: OTHER

Identifier Source: secondary_id

13/LO/0943

Identifier Type: -

Identifier Source: org_study_id