BlisterPhase 1NCT01120808
Prevention Trial Assessing Paper-Tape in Endurance Distances (PreTAPED)
A Phase 1 study testing Paper tape in people with Blister, run by Stanford University at 2 sites in United States.
Trial summary
Blisters are a very common complaint in both the general population and also the athlete. This study's aim is to determine whether applying paper tape (an inexpensive and common component of most foot care kits) to the foot of endurance runners prevents the frequency and severity of friction blisters. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blister
- What is being tested?
- Paper tape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Dec 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All runners who are enrolled in an RTP 4 deserts event,
- All runners who are 18-75 years old, and
- All runners who speak English. The study will be enrolling only those who speak English, so they can fully understand and have knowledgeable consent to the study enrollment protocols.
Who cannot join
- Any blisters, broken blisters, or hot spots present on either foot at the time of initial taping as determined by visual foot inspection by a enrolling study physician.
- The runner has a pre-existing blistering condition.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California Davis
Davis, California, 95616
Stanford University School of Medicine
Stanford, California, 94305
About this study
Blisters are a very common complaint in both the general population and also the athlete. This study's aim is to determine whether applying paper tape (an inexpensive and common component of most foot care kits) to the foot of endurance runners prevents the frequency and severity of friction blisters.
Read the detailed description
Participants will be approximately 100 ultra-endurance athletes competing in Racing the Planet's 250 mile/7 day 4 Desert ultra-endurance races. A convenience sample will be used, with full consent signed before inclusion into the study, with participants being informed that study inclusion is entirely optional and will not affect medical care. A foot will berandomly selected for each participant, a coin will be flipped to determine which foot is to be taped, heads - right foot, and tails, left foot. The non-taped foot will be used as a control. No preventive treatment will be applied to the control foot. The runner's normal sock/shoe system will be used to reflect natural wilderness conditions. Runners will be excluded if any blisters, broken blisters, or hot spots are present on either foot at the time of initial taping as determined by visual foot inspection by a study administrator. The participant will also be excluded if they have a pre-existing blistering condition or known sensitivity to paper tape. Participants will have demographic data collected prior to the race, including age, gender, country of origin, number of marathons run prior, pack weight, and sock type. The study endpoint occurs when a hot spot or blister develops on either the treated or untreated foot. Runners will be instructed to treat suspected blisters or hot spots as they normally would, and to inform the study administrators the same day for visual inspection and final questionnaire to determine if they develop blisters or hot spots, whether they applied or re-applied tape themselves, removed tape, and the reasons for these actions. Participants will be allowed to have their experimental taped foot re-taped by a physician at any point in the race as deemed necessary by the runner. Before applying tape, a visual inspection will determine that feet were clean of dirt and no hot spots or blisters / broken blisters were present. Tape will be applied by trained study physicians. One inch micropore paper tape from 3M will be applied to each toe in the following manner. A piece of tape will be placed on each toe longitudinally from the base of the phalanx dorsally to the base of the phalanx on the plantar side. The tape will be smoothed against the skin. Any tape extending beyond the tip of the phalanx will be adhered together. A second piece of one inch paper tape will be applied circumferentially around each toe, with the ends of the tape located on the dorsum of the toe. In this manner, all five toes on the experimental foot will be taped. Any "dog ears" (tape extending beyond the phalanges) will be then trimmed with a scissors. One 2 inch piece of micropore paper tape will be applied horizontally to the posterior heel over the Achilles tendon, extending from the posterior medial malleolus to the posterior lateral malleolus. One 2 inch piece of micropore tape will be applied perpendicular to the head of the 5th metatarsal, another perpendicular to the 1st metatarsal covering medial as well as plantar aspect.
- Conditions
- Blister
- Being tested
- Paper tape
- Medical subject headings
- Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper tapeProcedure or surgery
Paper tape assigned to each participant's randomly selected foot.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon. Receives: Procedure: Paper tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants With Blisters
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BlisterStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Principal investigator, Grant S Lipman, Stanford University
- Investigators
- Grant S Lipman, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120808
- Sponsor's protocol ID
- SU-04282010-5782
- Status last verified
- Nov 2018
- First submitted
- 7 May 2010
- Last updated
- 13 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lipman GS, Ellis MA, Lewis EJ, Waite BL, Lissoway J, Chan GK, Krabak BJ. A prospective randomized blister prevention trial assessing paper tape in endurance distances (Pre-TAPED). Wilderness Environ Med. 2014 Dec;25(4):457-61. doi: 10.1016/j.wem.2014.06.013. Epub 2014 Oct 31.
PubMed 25443754
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Trial Assessing Paper-Tape in Endurance Distances (PreTAPED)
- ClinicalTrials.gov ID
- NCT01120808
- Acronym / sponsor ID
- SU-04282010-5782
- Conditions
- Blister
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Posted 24 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blisters are a very common complaint in both the general population and also the athlete. This study's aim is to determine whether applying paper tape (an inexpensive and common component of most foot care kits) to the foot of endurance runners prevents the frequency and severity of friction blisters.
Detailed description
Participants will be approximately 100 ultra-endurance athletes competing in Racing the Planet's 250 mile/7 day 4 Desert ultra-endurance races. A convenience sample will be used, with full consent signed before inclusion into the study, with participants being informed that study inclusion is entirely optional and will not affect medical care. A foot will berandomly selected for each participant, a coin will be flipped to determine which foot is to be taped, heads - right foot, and tails, left foot. The non-taped foot will be used as a control. No preventive treatment will be applied to the control foot. The runner's normal sock/shoe system will be used to reflect natural wilderness conditions. Runners will be excluded if any blisters, broken blisters, or hot spots are present on either foot at the time of initial taping as determined by visual foot inspection by a study administrator. The participant will also be excluded if they have a pre-existing blistering condition or known sensitivity to paper tape. Participants will have demographic data collected prior to the race, including age, gender, country of origin, number of marathons run prior, pack weight, and sock type. The study endpoint occurs when a hot spot or blister develops on either the treated or untreated foot. Runners will be instructed to treat suspected blisters or hot spots as they normally would, and to inform the study administrators the same day for visual inspection and final questionnaire to determine if they develop blisters or hot spots, whether they applied or re-applied tape themselves, removed tape, and the reasons for these actions. Participants will be allowed to have their experimental taped foot re-taped by a physician at any point in the race as deemed necessary by the runner. Before applying tape, a visual inspection will determine that feet were clean of dirt and no hot spots or blisters / broken blisters were present. Tape will be applied by trained study physicians. One inch micropore paper tape from 3M will be applied to each toe in the following manner. A piece of tape will be placed on each toe longitudinally from the base of the phalanx dorsally to the base of the phalanx on the plantar side. The tape will be smoothed against the skin. Any tape extending beyond the tip of the phalanx will be adhered together. A second piece of one inch paper tape will be applied circumferentially around each toe, with the ends of the tape located on the dorsum of the toe. In this manner, all five toes on the experimental foot will be taped. Any "dog ears" (tape extending beyond the phalanges) will be then trimmed with a scissors. One 2 inch piece of micropore paper tape will be applied horizontally to the posterior heel over the Achilles tendon, extending from the posterior medial malleolus to the posterior lateral malleolus. One 2 inch piece of micropore tape will be applied perpendicular to the head of the 5th metatarsal, another perpendicular to the 1st metatarsal covering medial as well as plantar aspect.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Procedure: Paper tapeParticipants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All runners who are enrolled in an RTP 4 deserts event,
- All runners who are 18-75 years old, and
- All runners who speak English. The study will be enrolling only those who speak English, so they can fully understand and have knowledgeable consent to the study enrollment protocols.
Key exclusion criteria (2 listed)
- Any blisters, broken blisters, or hot spots present on either foot at the time of initial taping as determined by visual foot inspection by a enrolling study physician.
- The runner has a pre-existing blistering condition.
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 |
|---|---|---|
| Paper tapePaper tape assigned to each participant's randomly selected foot. | Procedure or surgery | All Participants |
Primary outcome
Count of Participants With Blisters
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25443754Lipman GS, Ellis MA, Lewis EJ, Waite BL, Lissoway J, Chan GK, Krabak BJ. A prospective randomized blister prevention trial assessing paper tape in endurance distances (Pre-TAPED). Wilderness Environ Med. 2014 Dec;25(4):457-61. doi: 10.1016/j.wem.2014.06.013. Epub 2014 Oct 31.
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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.
Grant S Lipman principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paper tape in people with Blister, run by Stanford University at 2 sites in United States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Participants With Blisters (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01120808, which also lists 1 linked publication.
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 13 Dec 2018.