ChilblainsNCT03101761
Characteristics and the Future of the City Chilblains
An observational study of Chilblains, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Chilblains are cutaneous lesions affecting extremities (foot and fingers) with erythemic papules, evolving by painful relapse due to cold and sudden reheating. This pathology is currently poorly understood while it's frequent. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chilblains
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2016to Feb 2017
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: every patient consulting for chilblains between 2012 and 2014
Who may be able to join
- patient consulting for chilblains
- diagnostic of chilblain during the consultation
Who cannot join
- patients consulting for other reason than chilblains
- patient who can't reply by telephonic call
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Chilblains are cutaneous lesions affecting extremities (foot and fingers) with erythemic papules, evolving by painful relapse due to cold and sudden reheating.
This pathology is currently poorly understood while it's frequent.
The aim of the study is to evaluate all the characteristics of this pathology by reporting clinical and biological data of patient consulting for chilblains; and the other point is to assess the evolution of these patients.
Read the detailed description
Investigators are going to collect data on patient medical report to fill up a case report form. And in a second time they call patient by phone to ask him/her about the evolution of their pathology.
- Conditions
- Chilblains
- Medical subject headings
- Chilblains
What is being measured
The primary outcome is the main question the study is designed to answer.
Évaluation of chilblains' topography
This assessment consists to evaluate the chilblains topography, vasospastic profile and presence or not of another acrosyndrome
Measured: Day 1
Secondary outcomes (1)
Questionnaire of assessment of chilblains' evolution
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 Feb 2016
- Primary completion31 Mar 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChilblainsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal PRIOLLET, MD, Study director, Groupe Hospitalier Paries St JOSEPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101761
- Sponsor's protocol ID
- ENGELURES
- Status last verified
- Mar 2017
- First submitted
- 17 Mar 2017
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and the Future of the City Chilblains
- ClinicalTrials.gov ID
- NCT03101761
- Acronym / sponsor ID
- ENGELURES
- Conditions
- Chilblains
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 5 Apr 2017 (actual)
- 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.
Chilblains are cutaneous lesions affecting extremities (foot and fingers) with erythemic papules, evolving by painful relapse due to cold and sudden reheating.
This pathology is currently poorly understood while it's frequent.
The aim of the study is to evaluate all the characteristics of this pathology by reporting clinical and biological data of patient consulting for chilblains; and the other point is to assess the evolution of these patients.
Detailed description
Investigators are going to collect data on patient medical report to fill up a case report form. And in a second time they call patient by phone to ask him/her about the evolution of their pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- every patient consulting for chilblains between 2012 and 2014
Key inclusion criteria (2 listed)
- patient consulting for chilblains
- diagnostic of chilblain during the consultation
Key exclusion criteria (2 listed)
- patients consulting for other reason than chilblains
- patient who can't reply by telephonic call
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Évaluation of chilblains' topography
Time frame: Day 1
This assessment consists to evaluate the chilblains topography, vasospastic profile and presence or not of another acrosyndrome
1 secondary outcome
Questionnaire of assessment of chilblains' evolution
Time frame: 2 months
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 5 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Chilblains
RecruitingObservational study
Assessment of Chilbains Occuring During Covid-19 Infection
Skin Manifestations, COVID
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.
Pascal PRIOLLET, MD study director
Groupe Hospitalier Paries St JOSEPH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chilblains, run by Fondation Hôpital Saint-Joseph 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 2 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 5 Apr 2017. 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?
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?
Évaluation of chilblains' topography (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 5 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.