Laser Speckle Contrast Imaging for Cutaneous Microvascular Dysfunction Detection in Systemic Sclerosis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-06-30

Brief Summary

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The aim of the study is to determine if postocclusive hyperemia of palmar and dorsal face of the hand with Laser speckle contrast imaging discriminate between patients with systemic sclerosis, subjects with primary Raynaud's phenomenon and healthy subjects.

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Detailed Description

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Microvascular dysfunction is a key event in the pathogenesis of systemic sclerosis. There are currently no test measuring it in clinical practice. Response to humeral occlusion is interesting and this response has been studied with laser Doppler flowmetry. More recently, laser imaging has been used analysing the granularity of the laser: laser Speckle Contrast Imaging which allow combining high temporal resolution to high spatial resolution.

The investigators proposed, in this study, to compare this imaging at basal and after post-occlusive hyperaemia of dorsal and palmar face of hand in 3 groups: healthy subjects, primary Raynaud's phenomenon and systemic sclerosis.

Conditions

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Raynaud Disease Scleroderma, Systemic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Sclerodermic patients

patients with systemic sclerosis according to Leroy's classification

Group Type EXPERIMENTAL

laser speckle contrast imaging

Intervention Type PROCEDURE

blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.

Cooling

Intervention Type PROCEDURE

blood flow of the hand recording during 30 minutes in a cooling-box

Primary Raynaud's phenomenon

without secondary disease

Group Type EXPERIMENTAL

laser speckle contrast imaging

Intervention Type PROCEDURE

blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.

Cooling

Intervention Type PROCEDURE

blood flow of the hand recording during 30 minutes in a cooling-box

Healthy subjects

18 years old or more

Group Type EXPERIMENTAL

laser speckle contrast imaging

Intervention Type PROCEDURE

blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.

Cooling

Intervention Type PROCEDURE

blood flow of the hand recording during 30 minutes in a cooling-box

Interventions

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laser speckle contrast imaging

blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.

Intervention Type PROCEDURE

Cooling

blood flow of the hand recording during 30 minutes in a cooling-box

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects:
* Man ou woman 18 years old or more.
* Without Raynaud's phenomenon or systemic sclerosis.

Raynaud's phenomenon subjects:

* Man ou woman 18 years old or more.
* with primary Raynaud's phenomenon.

Systemic sclerosis:

* Man ou woman 18 years old or more.
* systemic sclerosis in accordance to Leroy's classification.

Exclusion Criteria

* active digital ulceration
* Bosentan, iloprost ou sildenafil treatment
* History of axillary dissection , trauma or surgery
* history of thromboembolic disease or thrombophilia
* minor or law-protected major
* exclusion period in another study
* No affiliation to medicare
* pregnant, parturient or breasting woman
* concomitant serious disease: progressive cancer, liver failure, history of myocardial infarction less than 5 years, angor
* smoking in the 6 last months
* person deprived of liberty by a legal or administrative decision, person under legal protection
* maximal annual indemnification reached.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes