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

Not Applicable

• Conditions: Blister of Foot; Sport Injury
• Interventions: Other: Lemon foot to prevent blister

• Registration Number: NCT05086640
• Lead Sponsor: Institut de Formation et de Recherche en Médecine de Montagne

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-07-30
• Primary Completion: 2021-08-31
• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-10-07
• Last Update Submitted: 2021-10-07
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lemon foot	Lemon foot to prevent blister	Application of Lemon in the Prevention of Blisters on one feet

Primary Outcome Measures

Name	Time	Method
Presence or not of blisters at the end of the ultra-trail or at the time of abandonment.	up to 1 week	Blisters on each feet or non

Secondary Outcome Measures

Name	Time	Method
Feasibility of the protocole	up to 1 week	Easy to follow for runners, lemon used every day, how mutch misses
Tolerance	up to 1 week	Tolerance to the protocole
Severity of residual blisters	up to 1 week	Severity
Compliance	up to 1 week	Compliance to the protocole
Main locations of residual blisters	up to 1 week	Where on each feet

Trial Locations

Locations (1)

Ifremmont; 🇫🇷 Chamonix-Mont-Blanc, France