Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners (BS-2)

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.

Study Overview

• Status: Recruiting
• Conditions: Sport Injury; Blister of Foot
• Intervention / Treatment: Other: Lemon foot to prevent blister

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 Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lemon foot; Application of Lemon in the Prevention of Blisters on one feet	Other: 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.
No Intervention: Control foot without lemon; No application of Lemon or any other prevention cream in the Prevention of Blisters on one feet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut de Formation et de Recherche en Médecine de Montagne
• Investigators: Principal Investigator: Corentin Tanné, Institut de Formation et de Recherche en Médecine de Montagne

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): August 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: May 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 2

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