Blister of FootBS-2NCT05086640
Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners
A study testing Lemon foot to prevent blister in people with Blister of Foot and Sport Injury, run by Institut de Formation et de Recherche en Médecine de Montagne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blister of Foot, Sport Injury
- What is being tested?
- Lemon foot to prevent blister
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ultra-trail participants with validated registration
- Major (≥ 18 years old)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Ifremmont
Chamonix
Corentin Tanné, MD, 0450473105, C.Tanne@ch-sallanches-chamonix.fr
About this study
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.
Read more
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.
- Conditions
- Blister of Foot, Sport Injury
- Being tested
- Lemon foot to prevent blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemon foot to prevent blisterOther
The investigators make the hypothesis that the local application of Lemon allows a reduction of the number of blisters on ultra-trail.
| Study group | Role | What they receive |
|---|---|---|
| Lemon foot | Experimental | Application of Lemon in the Prevention of Blisters on one feet Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or not of blisters at the end of the ultra-trail or at the time of abandonment.
Blisters on each feet or non
Measured: up to 1 week
Secondary outcomes (5)
Feasibility of the protocole
Easy to follow for runners, lemon used every day, how mutch misses
Measured: up to 1 week
Compliance
Compliance to the protocole
Measured: up to 1 week
Tolerance
Tolerance to the protocole
Measured: up to 1 week
Main locations of residual blisters
Where on each feet
Measured: up to 1 week
Severity of residual blisters
Severity
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start30 Jul 2021
- Primary completion31 Aug 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blister of FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Formation et de Recherche en Médecine de Montagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corentin Tanné, Principal investigator, Institut de Formation et de Recherche en Médecine de Montagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086640
- Sponsor's protocol ID
- Blisters-stop 2
- Acronym
- BS-2
- Status last verified
- May 2021
- First submitted
- 3 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners
- ClinicalTrials.gov ID
- NCT05086640
- Acronym / sponsor ID
- BS-2 / Blisters-stop 2
- Conditions
- Blister of Foot, Sport Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Institut de Formation et de Recherche en Médecine de MontagneUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lemon foot | Experimental | Other: Lemon foot to prevent blisterApplication of Lemon in the Prevention of Blisters on one feet |
| Control foot without lemon | No intervention | –No application of Lemon or any other prevention cream in the Prevention of Blisters on one feet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ultra-trail participants with validated registration
- Major (≥ 18 years old)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemon foot to prevent blisterThe investigators make the hypothesis that the local application of Lemon allows a reduction of the number of blisters on ultra-trail. | Other | Lemon foot |
Primary outcome
Presence or not of blisters at the end of the ultra-trail or at the time of abandonment.
Time frame: up to 1 week
Blisters on each feet or non
5 secondary outcomes
Feasibility of the protocole
Time frame: up to 1 week
Compliance
Time frame: up to 1 week
Tolerance
Time frame: up to 1 week
Main locations of residual blisters
Time frame: up to 1 week
Severity of residual blisters
Time frame: up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Blister of Foot
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corentin Tanné principal investigator
Institut de Formation et de Recherche en Médecine de Montagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lemon foot to prevent blister in people with Blister of Foot and Sport Injury, run by Institut de Formation et de Recherche en Médecine de Montagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corentin Tanné, MD (0450473105, C.Tanne@ch-sallanches-chamonix.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or not of blisters at the end of the ultra-trail or at the time of abandonment. (time frame: up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.