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

Scleroderma, Systemic Clinical Trial

— SPECIES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743612
• Other study ID #: DCIC 11 25
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: June 1, 2016
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Raynaud Disease
• Scleroderma, Diffuse
• Scleroderma, Systemic

Intervention

Procedure:
• laser speckle contrast imaging
blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.
• Cooling
blood flow of the hand recording during 30 minutes in a cooling-box

Locations

Country	Name	City	State
France	Clinical Research Center	Grenoble
France	Vascular Medical Unit	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Primary	Post-occlusive hyperemia response between groups	The range of post-occlusive hyperemia response will be compared between the 3 arms.	30 minutes	No
Secondary	post-occlusive hyperemia response between zones	The range of post-occlusive hyperemia response will be compared between zones.	30 minutes	No
Secondary	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	No
Secondary	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	No
Secondary	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	No