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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University Hospital, Grenoble

Current Primary Outcome: Post-occlusive hyperemia response between groups [ Time Frame: 30 minutes ]

The range of post-occlusive hyperemia response will be compared between the 3 arms.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • post-occlusive hyperemia response between zones [ Time Frame: 30 minutes ]
    The range of post-occlusive hyperemia response will be compared between zones.
  • abnormal post-occlusive hyperemia response and finger pad scars [ Time Frame: 30 minutes ]
    comparison of range of post-occlusive hyperemia response with or without finger pad scars.
  • Entropy and Fourier transform [ Time Frame: 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 [ Time Frame: 30 minutes ]
    The Range of post-occlusive hyperemia response will be compared between the 2 hand faces (palmar and dorsal).


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: December 4, 2012
Date Started: January 2012
Date Completion:
Last Updated: June 1, 2016
Last Verified: December 2015