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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05071651
Other study ID # Blisters-stop 1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 6, 2021
Est. completion date December 12, 2021

Study information

Verified date August 2021
Source Institut de Formation et de Recherche en Médecine de Montagne
Contact Corentin Tanné, MD
Phone 0450473105
Email C.Tanne@ch-sallanches-chamonix.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 12, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ultra-trail participants with validated registration Exclusion Criteria: - Presence of blisters or other skin lesions on the feet before the race

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Ifremmont Chamonix-Mont-Blanc

Sponsors (1)

Lead Sponsor Collaborator
Institut de Formation et de Recherche en Médecine de Montagne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevention methods used before an ultra-trail via a self-questionnaire Prevention methods used before an ultra-trail Through study completion, an average of 1 year
Secondary Location of blisters, via a self-questionnaire Location of blisters on the feet Through study completion, an average of 1 year
Secondary Presence or not of blisters at the end of the ultra-trail or at the time of abandonment Presence or not of blisters at the end Through study completion, an average of 1 year
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