Raynaud DiseaseREFRAINNCT02183779
PORH and Response to Cold in Raynaud's Phenomenon.
A study testing post-occlusive hyperemia, cooling box and L-NMMA and Fluconazole dermic injection in people with Raynaud Disease and Hyperemia, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at… 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, Hyperemia, Cold
- What is being tested?
- post-occlusive hyperemia, cooling box and L-NMMA and Fluconazole dermic injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Jun 2017
- 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
- Neither raynaud's phenomenon or chronic disease for healthy volunteers
- Raynaud's phenomenon without connective tissue disease for patients in the group "Raynaud"
Who cannot join
- History of axillary dissection , trauma or surgery
- History of thromboembolic disease or thrombophilia
- Minor or law-protected major
- 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
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- 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
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre d'investigation clinique CIC1406
Grenoble Cedex9, 38043
Jean-Luc CRACOWSKI, MD-PhD, 33476769260, JLCracowski@chu-grenoble.fr
PARIS Adeline, PharmD-PhD, 33476767383, AParis@chu-grenoble.fr
About this study
Official title: Rôle Des Acides Epoxy-eicosatriénoïques et du Monoxyde d'Azote Dans l'hyperhémie Post-occlusive cutanée Digitale et la réponse cutanée au Froid Dans le phénomène de Raynaud Primaire
The main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.
Read the detailed description
The main objective of the study is to determine if implication of epoxy-eicosatriénoïques acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.
Healthy controls and patients will undergo 3 visits
- Conditions
- Raynaud Disease, Hyperemia, Cold
- Being tested
- post-occlusive hyperemia, cooling box, L-NMMA and Fluconazole dermic injection
- Keywords
- post-occlusive hyperaemia, laser-speckle contrast imaging, epoxyeicosatrienoic acid, nitrous oxide
- Medical subject headings
- Raynaud Disease, Hyperemia, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-occlusive hyperemiaProcedure or surgery
cooling boxProcedure or surgery
L-NMMA and Fluconazole dermic injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Reynaud | Experimental | patients with reynaud phenomena Receives: Procedure: post-occlusive hyperemia; Procedure: cooling box; Drug: L-NMMA and Fluconazole dermic injection |
| Healthy | Experimental | Healthy volunteers Receives: Procedure: post-occlusive hyperemia; Procedure: cooling box; Drug: L-NMMA and Fluconazole dermic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
post occlusive hyperemia amplitude
post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)
Measured: day 1
Secondary outcomes (3)
post occlusive hyperemia amplitude with anesthetic treatment
post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) treated with anesthetic
Measured: day1
cold-induced vasoconstriction amplitude
cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)
Measured: day 2
cold-induced vasoconstriction amplitude with anesthetic treatment
cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) with anesthetic local treatment
Measured: day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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, INSERM + University Hospital Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183779
- Sponsor's protocol ID
- DCIC 14 02
- Acronym
- REFRAIN
- Status last verified
- Dec 2015
- First submitted
- 1 Jul 2014
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rôle Des Acides Epoxy-eicosatriénoïques et du Monoxyde d'Azote Dans l'hyperhémie Post-occlusive cutanée Digitale et la réponse cutanée au Froid Dans le phénomène de Raynaud Primaire
- ClinicalTrials.gov ID
- NCT02183779
- Acronym / sponsor ID
- REFRAIN / DCIC 14 02
- Conditions
- Raynaud Disease, Hyperemia, Cold
- Keywords
- post-occlusive hyperaemia, laser-speckle contrast imaging, epoxyeicosatrienoic acid, nitrous oxide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 8 Jul 2014 (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 main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.
Detailed description
The main objective of the study is to determine if implication of epoxy-eicosatriénoïques acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.
Healthy controls and patients will undergo 3 visits
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reynaud | Experimental | Procedure: post-occlusive hyperemia, Procedure: cooling box, Drug: L-NMMA and Fluconazole dermic injectionpatients with reynaud phenomena |
| Healthy | Experimental | Procedure: post-occlusive hyperemia, Procedure: cooling box, Drug: L-NMMA and Fluconazole dermic injectionHealthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Neither raynaud's phenomenon or chronic disease for healthy volunteers
- Raynaud's phenomenon without connective tissue disease for patients in the group "Raynaud"
Key exclusion criteria (9 listed)
- History of axillary dissection , trauma or surgery
- History of thromboembolic disease or thrombophilia
- Minor or law-protected major
- No affiliation to medicare
- Pregnant, parturient or breasting woman
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 |
|---|---|---|
| post-occlusive hyperemia | Procedure or surgery | Healthy, Reynaud |
| cooling box | Procedure or surgery | Healthy, Reynaud |
| L-NMMA and Fluconazole dermic injection | Drug | Healthy, Reynaud |
Primary outcome
post occlusive hyperemia amplitude
Time frame: day 1
post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)
3 secondary outcomes
post occlusive hyperemia amplitude with anesthetic treatment
Time frame: day1
cold-induced vasoconstriction amplitude
Time frame: day 2
cold-induced vasoconstriction amplitude with anesthetic treatment
Time frame: day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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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
INSERM + University Hospital Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing post-occlusive hyperemia, cooling box and L-NMMA and Fluconazole dermic injection in people with Raynaud Disease and Hyperemia, run by University Hospital, Grenoble at 1 site 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Luc CRACOWSKI, MD-PhD (+33476769260, JLCracowski@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post occlusive hyperemia amplitude (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2015.