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

Primary Purpose

Blister of Foot, Sport Injury

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lemon foot to prevent blister
Sponsored by
Institut de Formation et de Recherche en Médecine de Montagne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blister of Foot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IfremmontRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lemon foot

Control foot without lemon

Arm Description

Application of Lemon in the Prevention of Blisters on one feet

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

Outcomes

Primary Outcome Measures

Presence or not of blisters at the end of the ultra-trail or at the time of abandonment.
Blisters on each feet or non

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2021
Last Updated
October 7, 2021
Sponsor
Institut de Formation et de Recherche en Médecine de Montagne
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1. Study Identification

Unique Protocol Identification Number
NCT05086640
Brief Title
Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners
Acronym
BS-2
Official Title
Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Formation et de Recherche en Médecine de Montagne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blister of Foot, Sport Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lemon foot
Arm Type
Experimental
Arm Description
Application of Lemon in the Prevention of Blisters on one feet
Arm Title
Control foot without lemon
Arm Type
No Intervention
Arm Description
No application of Lemon or any other prevention cream in the Prevention of Blisters on one feet
Intervention Type
Other
Intervention Name(s)
Lemon foot to prevent blister
Intervention Description
The investigators make the hypothesis that the local application of Lemon allows a reduction of the number of blisters on ultra-trail.
Primary Outcome Measure Information:
Title
Presence or not of blisters at the end of the ultra-trail or at the time of abandonment.
Description
Blisters on each feet or non
Time Frame
up to 1 week
Secondary Outcome Measure Information:
Title
Feasibility of the protocole
Description
Easy to follow for runners, lemon used every day, how mutch misses
Time Frame
up to 1 week
Title
Compliance
Description
Compliance to the protocole
Time Frame
up to 1 week
Title
Tolerance
Description
Tolerance to the protocole
Time Frame
up to 1 week
Title
Main locations of residual blisters
Description
Where on each feet
Time Frame
up to 1 week
Title
Severity of residual blisters
Description
Severity
Time Frame
up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corentin Tanné, MD
Phone
0450473105
Email
C.Tanne@ch-sallanches-chamonix.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corentin Tanné
Organizational Affiliation
Institut de Formation et de Recherche en Médecine de Montagne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ifremmont
City
Chamonix-Mont-Blanc
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corentin Tanné, MD
Phone
0450473105
Email
C.Tanne@ch-sallanches-chamonix.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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