PORH and Response to Cold in Raynaud's Phenomenon.

NCT ID: NCT02183779

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Raynaud Disease Hyperemia Cold

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

post-occlusive hyperaemia laser-speckle contrast imaging epoxyeicosatrienoic acid nitrous oxide

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reynaud

patients with reynaud phenomena

Group Type EXPERIMENTAL

post-occlusive hyperemia

Intervention Type PROCEDURE

cooling box

Intervention Type PROCEDURE

L-NMMA and Fluconazole dermic injection

Intervention Type DRUG

Healthy

Healthy volunteers

Group Type EXPERIMENTAL

post-occlusive hyperemia

Intervention Type PROCEDURE

cooling box

Intervention Type PROCEDURE

L-NMMA and Fluconazole dermic injection

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

post-occlusive hyperemia

Intervention Type PROCEDURE

cooling box

Intervention Type PROCEDURE

L-NMMA and Fluconazole dermic injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Neither raynaud's phenomenon or chronic disease for healthy volunteers
* Raynaud's phenomenon without connective tissue disease for patients in the group "Raynaud"

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean-Luc CRACOWSKI, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

INSERM + University Hospital Grenoble

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre d'investigation clinique CIC1406

Grenoble Cedex9, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jean-Luc CRACOWSKI, MD-PhD

Role: CONTACT

Phone: +33476769260

Email: [email protected]

Matthieu ROUSTIT, PharmD-PhD

Role: CONTACT

Phone: +33476769260

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jean-Luc CRACOWSKI, MD-PhD

Role: primary

PARIS Adeline, PharmD-PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DCIC 14 02

Identifier Type: -

Identifier Source: org_study_id