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

Sponsor
Institut de Formation et de Recherche en Médecine de Montagne (Other)
Overall Status
Recruiting
CT.gov ID
NCT05086640
Collaborator
(none)
82
1
2
5.1
16.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Lemon foot to prevent blister
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners
Actual Study Start Date :
Jul 30, 2021
Actual Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Feasibility of the protocole [up to 1 week]

    Easy to follow for runners, lemon used every day, how mutch misses

  2. Compliance [up to 1 week]

    Compliance to the protocole

  3. Tolerance [up to 1 week]

    Tolerance to the protocole

  4. Main locations of residual blisters [up to 1 week]

    Where on each feet

  5. Severity of residual blisters [up to 1 week]

    Severity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ifremmont Chamonix-Mont-Blanc France

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut de Formation et de Recherche en Médecine de Montagne
ClinicalTrials.gov Identifier:
NCT05086640
Other Study ID Numbers:
  • Blisters-stop 2
First Posted:
Oct 21, 2021
Last Update Posted:
Oct 21, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 21, 2021