Clinical trial NCT01743612: Laser Speckle Contrast Imaging for Cutaneous Microvascular Dysfunction Detection in Systemic Sclerosis.
Official title: Laser SPEckle Contrast Imaging Interest in dEtection of Cutaneous Microvascular Dysfunction in Systemic Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Raynaud Disease
Scleroderma, Systemic
Keywords: healthy subject
hand blood flow
laser speckle contrast imaging
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

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.

Primary outcomes:
measure: Post-occlusive hyperemia response between groups
timeFrame: 30 minutes
Secondary outcomes:
measure: post-occlusive hyperemia response between zones
timeFrame: 30 minutes
measure: abnormal post-occlusive hyperemia response and finger pad scars
timeFrame: 30 minutes
measure: Entropy and Fourier transform
timeFrame: 30 minutes
measure: Post-occlusive hyperemia response between the 2 faces
timeFrame: 30 minutes
Other outcomes:
measure: Blood flow after cooling between groups
timeFrame: 30 minutes
measure: reproductibility of hand cooling
timeFrame: Day 0 and Day 4
measure: blood flow after cooling in each group
timeFrame: 30 minutes
Locations:
city: Grenoble
country: France
facility: Clinical Research Center
city: Grenoble
country: France
facility: Vascular Medical Unit
Study officials:
affiliation: CIC, CHU Grenoble
name: Jean-Luc CRACOWSKI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaillard-Bigot F, Roustit M, Blaise S, Gabin M, Cracowski C, Seinturier C, Imbert B, Carpentier P, Cracowski JL. Abnormal amplitude and kinetics of digital postocclusive reactive hyperemia in systemic sclerosis. Microvasc Res. 2014 Jul;94:90-5. doi: 10.1016/j.mvr.2014.05.007. Epub 2014 Jun 2.