Laser Speckle Contrast Imaging for Cutaneous Microvascular Dysfunction Detection in Systemic Sclerosis.
- Conditions
- Raynaud DiseaseScleroderma, Systemic
- Interventions
- Procedure: laser speckle contrast imagingProcedure: Cooling
- Registration Number
- NCT01743612
- Lead Sponsor
- University Hospital, Grenoble
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy subjects Cooling 18 years old or more Healthy subjects laser speckle contrast imaging 18 years old or more Sclerodermic patients laser speckle contrast imaging patients with systemic sclerosis according to Leroy's classification Primary Raynaud's phenomenon laser speckle contrast imaging without secondary disease Sclerodermic patients Cooling patients with systemic sclerosis according to Leroy's classification Primary Raynaud's phenomenon Cooling without secondary disease
- Primary Outcome Measures
Name Time Method Post-occlusive hyperemia response between groups 30 minutes The range of post-occlusive hyperemia response will be compared between the 3 arms.
- Secondary Outcome Measures
Name Time Method abnormal post-occlusive hyperemia response and finger pad scars 30 minutes comparison of range of post-occlusive hyperemia response with or without finger pad scars.
Entropy and Fourier transform 30 minutes The interest of the signal analyses to distinguish systemic sclerosis, raynaud's phenomenon and healthy subjects will be studied with entropy and Fourier transform.
Post-occlusive hyperemia response between the 2 faces 30 minutes The Range of post-occlusive hyperemia response will be compared between the 2 hand faces (palmar and dorsal).
post-occlusive hyperemia response between zones 30 minutes The range of post-occlusive hyperemia response will be compared between zones.
Trial Locations
- Locations (2)
Clinical Research Center
🇫🇷Grenoble, France
Vascular Medical Unit
🇫🇷Grenoble, France