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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Laser SPEckle Contrast Imaging Interest in dEtection of Cutaneous Microvascular Dysfunction in Systemic Sclerosis.

Conditions
-----------------
Raynaud Disease, Scleroderma, Systemic

Intervention / Treatment
-----------------
* Procedure: laser speckle contrast imaging
* Procedure: Cooling


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sclerodermic patients<br>patients with systemic sclerosis according to Leroy's classification | Procedure: laser speckle contrast imaging<br>* blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.<br>Procedure: Cooling<br>* blood flow of the hand recording during 30 minutes in a cooling-box<br>|
| Experimental: Primary Raynaud's phenomenon<br>without secondary disease | Procedure: laser speckle contrast imaging<br>* blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.<br>Procedure: Cooling<br>* blood flow of the hand recording during 30 minutes in a cooling-box<br>|
| Experimental: Healthy subjects<br>18 years old or more | Procedure: laser speckle contrast imaging<br>* blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.<br>Procedure: Cooling<br>* blood flow of the hand recording during 30 minutes in a cooling-box<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-occlusive hyperemia response between groups | The range of post-occlusive hyperemia response will be compared between the 3 arms. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-occlusive hyperemia response between zones | The range of post-occlusive hyperemia response will be compared between zones. | 30 minutes | 
| abnormal post-occlusive hyperemia response and finger pad scars | comparison of range of post-occlusive hyperemia response with or without finger pad scars. | 30 minutes | 
| Entropy and Fourier transform | The interest of the signal analyses to distinguish systemic sclerosis, raynaud's phenomenon and healthy subjects will be studied with entropy and Fourier transform. | 30 minutes | 
| Post-occlusive hyperemia response between the 2 faces | The Range of post-occlusive hyperemia response will be compared between the 2 hand faces (palmar and dorsal). | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subject, hand blood flow, laser speckle contrast imaging