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

NCT05086640 | Unknown

• 1 other identifier: Blisters-stop 2
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Blister of Foot; Sport Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Feasibility of the protocole

  up to 1 week

• Compliance

  up to 1 week

• Tolerance

  up to 1 week

• Main locations of residual blisters

  up to 1 week

• Severity of residual blisters

  up to 1 week

Study Arms (2)

Lemon foot

EXPERIMENTAL

Application of Lemon in the Prevention of Blisters on one feet

Other: Lemon foot to prevent blister

Control foot without lemon

NO INTERVENTION

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

Interventions

Lemon foot to prevent blister OTHER

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

Lemon foot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de Formation et de Recherche en Médecine de Montagne: lead

Study Sites (1)

Ifremmont

Chamonix, France

RECRUITING

Study Officials

• Corentin Tanné

  Institut de Formation et de Recherche en Médecine de Montagne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corentin Tanné, MD

CONTACT

0450473105; C.Tanne@ch-sallanches-chamonix.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: October 21, 2021
• Study Start: July 30, 2021
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)