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

Sport Injury Clinical Trial

Official title:

Caractéristiques épidémiologiques et méthodes de prévention Des Ampoules Chez Les Coureurs d'Ultra-trail

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05071651
• Other study ID #: Blisters-stop 1
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Athletic Injuries
• Blister
• Blister of Foot
• Sport Injury

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