Raynaud DiseaseSPECIESNCT01743612
Laser Speckle Contrast Imaging for Cutaneous Microvascular Dysfunction Detection in Systemic Sclerosis.
A study testing laser speckle contrast imaging and Cooling in people with Raynaud Disease and Scleroderma, Systemic, run by University Hospital, Grenoble at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Raynaud Disease, Scleroderma, Systemic
- What is being tested?
- laser speckle contrast imaging and Cooling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Systemic sclerosis:
- Man ou woman 18 years old or more.
- systemic sclerosis in accordance to Leroy's classification.
Who cannot join
- 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
- No affiliation to medicare
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- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinical Research Center
Grenoble, 38043
Vascular Medical Unit
Grenoble, 38043
About this study
Official title: Laser SPEckle Contrast Imaging Interest in dEtection of Cutaneous Microvascular Dysfunction 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.
Read the 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.
- Conditions
- Raynaud Disease, Scleroderma, Systemic
- Being tested
- laser speckle contrast imaging, Cooling
- Keywords
- healthy subject, hand blood flow, laser speckle contrast imaging
- Medical subject headings
- Raynaud Disease, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser speckle contrast imagingProcedure or surgery
blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.
CoolingProcedure or surgery
blood flow of the hand recording during 30 minutes in a cooling-box
| Study group | Role | What they receive |
|---|---|---|
| Sclerodermic patients | Experimental | patients with systemic sclerosis according to Leroy's classification Receives: Procedure: laser speckle contrast imaging; Procedure: Cooling |
| Primary Raynaud's phenomenon | Experimental | without secondary disease Receives: Procedure: laser speckle contrast imaging; Procedure: Cooling |
| Healthy subjects | Experimental | 18 years old or more Receives: Procedure: laser speckle contrast imaging; Procedure: Cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-occlusive hyperemia response between groups
The range of post-occlusive hyperemia response will be compared between the 3 arms.
Measured: 30 minutes
Secondary outcomes (4)
post-occlusive hyperemia response between zones
The range of post-occlusive hyperemia response will be compared between zones.
Measured: 30 minutes
abnormal post-occlusive hyperemia response and finger pad scars
comparison of range of post-occlusive hyperemia response with or without finger pad scars.
Measured: 30 minutes
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.
Measured: 30 minutes
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).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Raynaud DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc CRACOWSKI, MD, PhD, Principal investigator, CIC, CHU Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743612
- Sponsor's protocol ID
- DCIC 11 25
- Acronym
- SPECIES
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2012
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaillard-Bigot F, Roustit M, Blaise S, Gabin M, Cracowski C, Seinturier C, Imbert B, Carpentier P, Cracowski JL. Abnormal amplitude and kinetics of digital postocclusive reactive hyperemia in systemic sclerosis. Microvasc Res. 2014 Jul;94:90-5. doi: 10.1016/j.mvr.2014.05.007. Epub 2014 Jun 2.
PubMed 24990822
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser SPEckle Contrast Imaging Interest in dEtection of Cutaneous Microvascular Dysfunction in Systemic Sclerosis.
- ClinicalTrials.gov ID
- NCT01743612
- Acronym / sponsor ID
- SPECIES / DCIC 11 25
- Conditions
- Raynaud Disease, Scleroderma, Systemic
- Keywords
- healthy subject, hand blood flow, laser speckle contrast imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sclerodermic patients | Experimental | Procedure: laser speckle contrast imaging, Procedure: Coolingpatients with systemic sclerosis according to Leroy's classification |
| Primary Raynaud's phenomenon | Experimental | Procedure: laser speckle contrast imaging, Procedure: Coolingwithout secondary disease |
| Healthy subjects | Experimental | Procedure: laser speckle contrast imaging, Procedure: Cooling18 years old or more |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy subjects:
- Man ou woman 18 years old or more.
- Without Raynaud's phenomenon or systemic sclerosis.
- Man ou woman 18 years old or more.
- with primary Raynaud's phenomenon.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laser speckle contrast imagingblood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes. | Procedure or surgery | Healthy subjects, Primary Raynaud's phenomenon, Sclerodermic patients |
| Coolingblood flow of the hand recording during 30 minutes in a cooling-box | Procedure or surgery | Healthy subjects, Primary Raynaud's phenomenon, Sclerodermic patients |
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.
4 secondary outcomes
post-occlusive hyperemia response between zones
Time frame: 30 minutes
abnormal post-occlusive hyperemia response and finger pad scars
Time frame: 30 minutes
Entropy and Fourier transform
Time frame: 30 minutes
Post-occlusive hyperemia response between the 2 faces
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Derived from this study: PubMed 24990822Gaillard-Bigot F, Roustit M, Blaise S, Gabin M, Cracowski C, Seinturier C, Imbert B, Carpentier P, Cracowski JL. Abnormal amplitude and kinetics of digital postocclusive reactive hyperemia in systemic sclerosis. Microvasc Res. 2014 Jul;94:90-5. doi: 10.1016/j.mvr.2014.05.007. Epub 2014 Jun 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc CRACOWSKI, MD, PhD principal investigator
CIC, CHU Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser speckle contrast imaging and Cooling in people with Raynaud Disease and Scleroderma, Systemic, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-occlusive hyperemia response between groups (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01743612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2016; AzTrials last refreshed its copy on 27 Oct 2026.