Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners

NCT ID: NCT05086640

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-30

Study Completion Date

2021-12-31

Brief Summary

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For more than a decade, worldwide participation in ultra-marathons and ultra-trails (running races longer than the 42.195 km marathon) has been increasing. Although considered benign, blisters are a common problem, with serious consequences and limiting performance.

Although blisters are a major factor limiting endurance performance, they are a reason for only 5.8% of ultra-trail runners to quit.

While equipment is improving and participants are increasing and intensifying their training, there is no consensus on the prevention of blisters in ultra-trail running, even though it is the number one factor limiting sports performance. There are few prospective interventional studies on the prevention of blisters during outdoor activities.

On many running forums, there is the hypothesis that lemon applied to the feet prevents the appearance of blisters. This hypothesis has never been scientifically studied.

The investigators hypothesize that the local application of Lemon allows a reduction in the number of blisters on ultra-trail.

The objective of this Blisters-stop 2 study is to evaluate the efficacy of local application of Lemon in preventing the appearance of blisters.

Detailed Description

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The patients included will be runners registered in a trail of a distance greater than 40km for whom Lemon will be applied on the friction zones of one foot as a preventive measure (28 days).

The study is coordinated by IFREMMONT and the Pays du Mont Blanc Hospitals and 82 patients must be included in order to obtain statistical significance.

Conditions

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Blister of Foot Sport Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lemon foot

Application of Lemon in the Prevention of Blisters on one feet

Group Type EXPERIMENTAL

Lemon foot to prevent blister

Intervention Type OTHER

The investigators make the hypothesis that the local application of Lemon allows a reduction of the number of blisters on ultra-trail.

Control foot without lemon

No application of Lemon or any other prevention cream in the Prevention of Blisters on one feet

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lemon foot to prevent blister

The investigators make the hypothesis that the local application of Lemon allows a reduction of the number of blisters on ultra-trail.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ultra-trail participants with validated registration
* Major (≥ 18 years old)

Exclusion Criteria

* Presence of blisters or other skin lesions on the feet 28 days before the race
* Amputation of one or two feet
* Allergy to lemon
* Psychiatric disorders making comprehension impossible
* Lack of social security coverage
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut de Formation et de Recherche en Médecine de Montagne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corentin Tanné

Role: PRINCIPAL_INVESTIGATOR

Institut de Formation et de Recherche en Médecine de Montagne

Locations

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Ifremmont

Chamonix, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Corentin Tanné, MD

Role: CONTACT

0450473105

Facility Contacts

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Corentin Tanné, MD

Role: primary

0450473105

Other Identifiers

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Blisters-stop 2

Identifier Type: -

Identifier Source: org_study_id