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Epidemiological Characteristics and Prevention Methods of Blisters in Ultra-trail Runners

Sponsor
Institut de Formation et de Recherche en Médecine de Montagne (Other)
Overall Status
Recruiting
CT.gov ID
NCT05071651
Collaborator
(none)
500
Enrollment
1
Location
8.2
Anticipated Duration (Months)
60.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

PRIMARY OBJECTIVE : To evaluate the methods of prevention of the appearance of blisters set up by the runners before and during an ultra-trail

SECONDARY OBJECTIVES :
To evaluate :

  • The main locations of blisters.

  • The severity of blisters

  • The effectiveness of prevention methods To evaluate the incidence of blisters in an ultra-trail context.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    MAIN JUDGEMENT CRITERIA :

    Prevention methods used before an ultra-trail via a self-questionnaire

    SECONDARY JUDGING CRITERIA : Location of blisters, via a self-questionnaire Presence or not of blisters at the end of the ultra-trail or at the time of abandonment

    STUDY SCHEME : Post-race questioning

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Caractéristiques épidémiologiques et méthodes de prévention Des Ampoules Chez Les Coureurs d'Ultra-trail
    Actual Study Start Date :
    Apr 6, 2021
    Actual Primary Completion Date :
    Aug 31, 2021
    Anticipated Study Completion Date :
    Dec 12, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Prevention methods used before an ultra-trail via a self-questionnaire [Through study completion, an average of 1 year]

      Prevention methods used before an ultra-trail

    Secondary Outcome Measures

    1. Location of blisters, via a self-questionnaire [Through study completion, an average of 1 year]

      Location of blisters on the feet

    2. Presence or not of blisters at the end of the ultra-trail or at the time of abandonment [Through study completion, an average of 1 year]

      Presence or not of blisters at the end

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Ultra-trail participants with validated registration
    Exclusion Criteria:
    • Presence of blisters or other skin lesions on the feet before the race

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ifremmont Chamonix-Mont-Blanc France

    Sponsors and Collaborators

    • Institut de Formation et de Recherche en Médecine de Montagne

    Investigators

    • Principal Investigator: Corentin Tanné, MD, Institut de Formation et de Recherche en Médecine de Montagne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Institut de Formation et de Recherche en Médecine de Montagne
    ClinicalTrials.gov Identifier:
    NCT05071651
    Other Study ID Numbers:
    • Blisters-stop 1
    First Posted:
    Oct 8, 2021
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Blister
    Athletic Injuries

    Study Results

    No Results Posted as of Oct 8, 2021