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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sport Injury; Blister of Foot

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Corentin Tanné, MD; Phone Number: 0450473105; Email: C.Tanne@ch-sallanches-chamonix.fr

Study Locations

• France
  • Chamonix-Mont-Blanc, France
    • Recruiting
    • Ifremmont
    • Contact: Corentin Tanné, MD; Phone Number: 0450473105; Email: C.Tanne@ch-sallanches-chamonix.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ultra runners

Description

Inclusion Criteria:

• Ultra-trail participants with validated registration

Exclusion Criteria:

• Presence of blisters or other skin lesions on the feet before the race

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Location of blisters, via a self-questionnaire	Location of blisters on the feet	Through study completion, an average of 1 year
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Anticipated): December 12, 2021

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Pathological Conditions, Anatomical; Skin Diseases, Vesiculobullous; Blister; Athletic Injuries
• Other Study ID Numbers: Blisters-stop 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No