- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01743612
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Grenoble, France, 38043
- Clinical Research Center
-
Grenoble, France, 38043
- Vascular Medical Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sclerodermic patients
patients with systemic sclerosis according to Leroy's classification
|
blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.
blood flow of the hand recording during 30 minutes in a cooling-box
|
Experimental: Primary Raynaud's phenomenon
without secondary disease
|
blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.
blood flow of the hand recording during 30 minutes in a cooling-box
|
Experimental: Healthy subjects
18 years old or more
|
blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.
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
Time Frame: 30 minutes
|
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
Time Frame: 30 minutes
|
The range of post-occlusive hyperemia response will be compared between zones.
|
30 minutes
|
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.
|
30 minutes
|
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.
|
30 minutes
|
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).
|
30 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 minutes
|
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.
|
Day 0 and Day 4
|
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.
|
30 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Luc CRACOWSKI, MD, PhD, CIC, CHU Grenoble
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCIC 11 25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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