NCT03101761

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
Last Updated

April 5, 2017

Status Verified

March 1, 2017

Enrollment Period

2 months

First QC Date

March 17, 2017

Last Update Submit

March 29, 2017

Conditions

Chilblains

Outcome Measures

Primary Outcomes (1)

  • Évaluation of chilblains' topography

    This assessment consists to evaluate the chilblains topography, vasospastic profile and presence or not of another acrosyndrome

    Day 1

Secondary Outcomes (1)

  • Questionnaire of assessment of chilblains' evolution

    2 months

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

every patient consulting for chilblains between 2012 and 2014

You may qualify if:

  • patient consulting for chilblains
  • diagnostic of chilblain during the consultation

You may not qualify if:

  • patients consulting for other reason than chilblains
  • patient who can't reply by telephonic call

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Conditions

Chilblains

Condition Hierarchy (Ancestors)

FrostbiteCold InjuryWounds and Injuries

Study Officials

  • Pascal PRIOLLET, MD

    Groupe Hospitalier Paries St JOSEPH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2017

First Posted

April 5, 2017

Study Start

February 1, 2016

Primary Completion

March 31, 2016

Study Completion

February 1, 2017

Last Updated

April 5, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)