Trial record 11 of 44 for:
"Raynaud Disease"
Laser Speckle Contrast Imaging for Cutaneous Microvascular Dysfunction Detection in Systemic Sclerosis. (SPECIES)
This study is currently recruiting participants.
Verified December 2012 by University Hospital, Grenoble
Sponsor:
University Hospital, Grenoble
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01743612
First received: December 4, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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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.
We 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: | December 4, 2012 |
| Health Authority: | France: L’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 May 16, 2013