Epidemiological Characteristics and Prevention Methods of... | NCT05071651

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

NCT05071651

Sponsor

Institut de Formation et de Recherche en Médecine de Montagne

Status

Unknown status

Last Update Posted

Oct 8, 2021Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Sport Injury
Blister of Foot

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 6, 2021Actual

Primary Completion Date

Aug 31, 2021Actual

Completion Date

Dec 12, 2021Estimated

First Submitted Date

Aug 23, 2021

First Submission Date that Met QC Criteria

Oct 7, 2021

First Posted Date

Oct 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2021

Last Update Posted Date

Oct 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ultra-trail participants with validated registration

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ultra runners

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Corentin Tanné, MD	Contact	0450473105		C.Tanne@ch-sallanches-chamonix.fr

Overall Officials

Name	Affiliation	Role
Corentin Tanné, MD	Institut de Formation et de Recherche en Médecine de Montagne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ifremmont	Recruiting	Chamonix			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Dec 17, 2021
Reset	Mar 9, 2022

Submission Tracking

Estimated Results First Submitted Date

Dec 17, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 17, 2021			Mar 9, 2022