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

This study is currently recruiting participants.
Verified July 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01743612
First received: December 4, 2012
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Raynaud Disease
Scleroderma, Systemic
Procedure: laser speckle contrast imaging
Procedure: Cooling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Laser SPEckle Contrast Imaging Interest in dEtection of Cutaneous Microvascular Dysfunction in Systemic Sclerosis.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Post-occlusive hyperemia response between groups [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The range of post-occlusive hyperemia response will be compared between the 3 arms.


Secondary Outcome Measures:
  • post-occlusive hyperemia response between zones [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    comparison of range of post-occlusive hyperemia response with or without finger pad scars.

  • Entropy and Fourier transform [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The Range of post-occlusive hyperemia response will be compared between the 2 hand faces (palmar and dorsal).


Other Outcome Measures:
  • Blood flow after cooling between groups [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Range of the diminution of blood flow in palmar and dorsal hand faces will be compared in the 3 groups

  • reproductibility of hand cooling [ Time Frame: Day 0 and Day 4 ] [ Designated as safety issue: No ]
    The reproductibility of the measure of blood flow after cooling will be studied twice, at day0 and 4 days later.

  • blood flow after cooling in each group [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    The range of blood flow after cooling on pulpar and dorsal face of hand will be compared between the 3 groups.


Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743612

Contacts
Contact: Jean-Luc CRACOWSKI, MD, PhD 0033476769260 jlcracowski@chu-grenoble.fr
Contact: Matthieu Roustit, PharmD, PhD 003476769260 MRoustit@chu-grenoble.fr

Locations
France
Clinical Research Center Recruiting
Grenoble, France, 38043
Contact: Jean-Luc CRACOWSKI, MD, PhD    0033476769260    JLCracowski@chu-grenoble.fr   
Contact: Matthieu Roustit, PharmD, PhD    0033476769260    MRoustit@chu-grenoble.fr   
Principal Investigator: Jean-Luc CRACOWSKI, MD, PhD         
Sub-Investigator: Claire Cracowski, MD         
Vascular Medical Unit Recruiting
Grenoble, France, 38043
Contact: Sophie Blaise, MD, PhD       SBlaise@chu-grenoble.fr   
Sub-Investigator: Patrick Carpentier, MD, PhD         
Sub-Investigator: Sophie Blaise, MD, PhD         
Sub-Investigator: Christophe Ceinturier, MD         
Sub-Investigator: Bernard Imbert, MD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Luc CRACOWSKI, MD, PhD CIC, CHU Grenoble
  More Information

No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01743612     History of Changes
Other Study ID Numbers: DCIC 11 25
Study First Received: December 4, 2012
Last Updated: July 17, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Grenoble:
healthy subject
hand blood flow
laser speckle contrast imaging

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Raynaud Disease
Sclerosis
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 20, 2014