Sport InjuryNCT05071651
Epidemiological Characteristics and Prevention Methods of Blisters in Ultra-trail Runners
An observational study of Sport Injury and Blister of Foot, run by Institut de Formation et de Recherche en Médecine de Montagne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sport Injury, Blister of Foot
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2021to 12 Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ultra runners
Who may be able to join
- Ultra-trail participants with validated registration
Who cannot join
- Presence of blisters or other skin lesions on the feet before the race
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Ifremmont
Chamonix
Corentin Tanné, MD, 0450473105, C.Tanne@ch-sallanches-chamonix.fr
About this study
Official title: 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.
Read the 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
- Conditions
- Sport Injury, Blister of Foot
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention methods used before an ultra-trail via a self-questionnaire
Prevention methods used before an ultra-trail
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Location of blisters, via a self-questionnaire
Location of blisters on the feet
Measured: 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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start6 Apr 2021
- Primary completion31 Aug 2021
- Study completion12 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Institut de Formation et de Recherche en Médecine de Montagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corentin Tanné, MD, Principal investigator, Institut de Formation et de Recherche en Médecine de Montagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071651
- Sponsor's protocol ID
- Blisters-stop 1
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caractéristiques épidémiologiques et méthodes de prévention Des Ampoules Chez Les Coureurs d'Ultra-trail
- ClinicalTrials.gov ID
- NCT05071651
- Acronym / sponsor ID
- Blisters-stop 1
- Conditions
- Sport Injury, Blister of Foot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institut de Formation et de Recherche en Médecine de MontagneUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 12 Dec 2021 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ultra runners
Key inclusion criteria (1 listed)
- Ultra-trail participants with validated registration
Key exclusion criteria (1 listed)
- Presence of blisters or other skin lesions on the feet before the race
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevention methods used before an ultra-trail via a self-questionnaire
Time frame: Through study completion, an average of 1 year
Prevention methods used before an ultra-trail
2 secondary outcomes
Location of blisters, via a self-questionnaire
Time frame: 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
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corentin Tanné, MD principal investigator
Institut de Formation et de Recherche en Médecine de Montagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sport Injury and Blister of Foot, run by Institut de Formation et de Recherche en Médecine de Montagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corentin Tanné, MD (0450473105, C.Tanne@ch-sallanches-chamonix.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention methods used before an ultra-trail via a self-questionnaire (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.