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Completed

NCT Number: NCT01743612

Laser Speckle Contrast Imaging for Cutaneous Microvascular Dysfunction Detection 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center, Grenoble, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laser speckle contrast imaging

Procedure

blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.

cooling

Procedure

blood flow of the hand recording during 30 minutes in a cooling-box

Primary outcomes

  1. Post-occlusive hyperemia response between groups

    Time frame: 30 minutes

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

Secondary outcomes

  1. post-occlusive hyperemia response between zones

    Time frame: 30 minutes

    The range of post-occlusive hyperemia response will be compared between zones.

  2. 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.

  3. 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.

  4. 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).

Other outcomes

  1. Blood flow after cooling between groups

    Time frame: 30 minutes

    Range of the diminution of blood flow in palmar and dorsal hand faces will be compared in the 3 groups

  2. reproductibility of hand cooling

    Time frame: Day 0 and Day 4

    The reproductibility of the measure of blood flow after cooling will be studied twice, at day0 and 4 days later.

  3. blood flow after cooling in each group

    Time frame: 30 minutes

    The range of blood flow after cooling on pulpar and dorsal face of hand will be compared between the 3 groups.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: SPECIES

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2012
Registry last updated
Jun 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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