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

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

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.

Study Overview

• Status: Completed
• Conditions: Scleroderma, Systemic; Raynaud Disease
• Intervention / Treatment: Procedure: laser speckle contrast imaging; Procedure: Cooling

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Clinical Research Center
  • Grenoble, France, 38043
    • Vascular Medical Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood flow after cooling between groups	Range of the diminution of blood flow in palmar and dorsal hand faces will be compared in the 3 groups	30 minutes
reproductibility of hand cooling	The reproductibility of the measure of blood flow after cooling will be studied twice, at day0 and 4 days later.	Day 0 and Day 4
blood flow after cooling in each group	The range of blood flow after cooling on pulpar and dorsal face of hand will be compared between the 3 groups.	30 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Jean-Luc CRACOWSKI, MD, PhD, CIC, CHU Grenoble

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Estimate): June 2, 2016
• Last Update Submitted That Met QC Criteria: June 1, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: healthy subject; laser speckle contrast imaging; hand blood flow
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Connective Tissue Diseases; Peripheral Vascular Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Raynaud Disease
• Other Study ID Numbers: DCIC 11 25