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

Sport Injury Clinical Trial

— BS-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05086640
• Other study ID #: Blisters-stop 2
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Institut de Formation et de Recherche en Médecine de Montagne
• Contact: Corentin Tanné, MD
• Phone: 0450473105
• Email: C.Tanne[@]ch-sallanches-chamonix.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Athletic Injuries
• Blister
• Blister of Foot
• Sport Injury

Intervention

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.

Locations

Country	Name	City	State
France	Ifremmont	Chamonix-Mont-Blanc

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Formation et de Recherche en Médecine de Montagne

Country where clinical trial is conducted

France, 

Outcome

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