ClinicalTrials.gg
Status unknownNCT05086640BS-2Updated Oct 21, 2021

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

An interventional study of Lemon foot to prevent blister in Blister of Foot and Sport Injury, sponsored by Institut de Formation et de Recherche en Médecine de Montagne. Status unknown at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-21.

Sponsored by Institut de Formation et de Recherche en Médecine de Montagne · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Blister of Foot
  • Sport Injury
03

In context

Athletic Injuries

258 studies on the registry are indexed under Athletic Injuries; 45 are open to participants now.

This study's planned enrollment of 82 is above the median of 44 across 164 interventional studies indexed under Athletic Injuries.

Browse Athletic Injuries studies →

Lead sponsor

Institut de Formation et de Recherche en Médecine de Montagne is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants (estimated)

Study arms

  • Experimental
    Lemon foot

    Application of Lemon in the Prevention of Blisters on one feet

    Other: Lemon foot to prevent blister

  • No intervention
    Control foot without lemon

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

Interventions

  • OtherLemon 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.

06

What researchers measure

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

    Time frame: up to 1 week

Secondary outcomes

  1. Feasibility of the protocole

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

    Time frame: up to 1 week

  2. Compliance

    Compliance to the protocole

    Time frame: up to 1 week

  3. Tolerance

    Tolerance to the protocole

    Time frame: up to 1 week

  4. Main locations of residual blisters

    Where on each feet

    Time frame: up to 1 week

  5. Severity of residual blisters

    Severity

    Time frame: up to 1 week

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05086640
Lead sponsor
Institut de Formation et de Recherche en Médecine de Montagne
Responsible party
Sponsor
First posted
Oct 21, 2021
Start date
Jul 30, 2021
Primary completion
Aug 31, 2021
Completion
Dec 31, 2021 (estimated)
Last update
Oct 21, 2021

Study contacts

Corentin Tanné, MD
Contact
C.Tanne@ch-sallanches-chamonix.fr
0450473105
Corentin Tanné
principal investigator · Institut de Formation et de Recherche en Médecine de Montagne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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