Blister of FootNCT01945112
Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II)
A study testing Paper Tape in people with Blister of Foot, run by Stanford University at 1 site in United States.
Trial summary
Friction foot blisters are one of the most common and often debilitating complaints of all athletes, and hikers and runners in particular. Blistering rates in the literature of outdoor hikers range from 7%-54%. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blister of Foot
- What is being tested?
- Paper Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jul 2015
- Phase
- Interventional
- 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
- Any runner who are enrolled in an RTP 4 deserts event, All runners who are 18-75 years old All runners who speak or read English. The study will be enrolling only those who speak or read 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 researcher.
- The runner allergic to paper-tape.
Trial locations and contacts
1 site in 1 country.
About this study
Friction foot blisters are one of the most common and often debilitating complaints of all athletes, and hikers and runners in particular. Blistering rates in the literature of outdoor hikers range from 7%-54%. This study's aim is to build on Pre-TAPED I, and determine whether applying paper tape to the areas of the foot where blisters historically occur in endurance runners can prevent the incidence of friction blisters.
Read the detailed description
Participants will be ultra-endurance athletes competing in Racing the Planet's 250 mile/7 day 4 Desert events in 2014 (Jordan, Gobi, Madagascar, and Atacama. 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. Randomization will be conducted 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. The runner's normal sock/shoe system will be used to reflect natural wilderness conditions. 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 have tape applied to area(s) prone to blister on 1 foot, if no blister history, 1 area will be randomly assigned. The tape will be left on the selected foot until a blister or hot spot develops on either foot or the end of the race, whichever comes first. At that point, the study is over and the participant can continue or stop taping at their choice. If participants are prone to blisters or hot spots in particular areas, 1" paper tape applied to that site on trial foot. However, if the participant has no previous blister or hot spot experience, a site will be randomly assigned by picking a piece of paper out of a bag with the site written on a piece of paper (heel, toe, instep, head of 5th metatarsal). Therefore, a single participant can have more than 1 site on an individual foot.
- Conditions
- Blister of Foot
- Being tested
- Paper Tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paper TapeDevice
Applied to blister prone areas of the foot
| Study group | Role | What they receive |
|---|---|---|
| Paper Tape | Experimental | Paper tape will be applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control. Receives: Device: Paper Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants With Any Foot Blister in Taped or Untaped Area of the Foot
Blister data were collected without regard to whether the foot was right or left.
Measured: within 7 days of application of tape
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startFeb 2014
- Primary completionJul 2015
- Study completionJul 2015
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 Blister of FootStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Resurrection Medical Center
- Responsible party
- Principal investigator, Grant S Lipman, Stanford University
- Investigators
- Grant S Lipman, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945112
- Sponsor's protocol ID
- 28548
- Status last verified
- Nov 2018
- First submitted
- 13 Sep 2013
- Last updated
- 12 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lipman GS, Sharp LJ, Christensen M, Phillips C, DiTullio A, Dalton A, Ng P, Shangkuan J, Shea K, Krabak BJ. Paper Tape Prevents Foot Blisters: A Randomized Prevention Trial Assessing Paper Tape in Endurance Distances II (Pre-TAPED II). Clin J Sport Med. 2016 Sep;26(5):362-8. doi: 10.1097/JSM.0000000000000319.
PubMed 27070112
Study at a glance
From the registry record, last updated by the sponsor on 12 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 II (Pre-TAPED II)
- ClinicalTrials.gov ID
- NCT01945112
- Acronym / sponsor ID
- 28548
- Conditions
- Blister of Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Resurrection Medical Center
- Study start
- Feb 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Posted 16 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Friction foot blisters are one of the most common and often debilitating complaints of all athletes, and hikers and runners in particular. Blistering rates in the literature of outdoor hikers range from 7%-54%. This study's aim is to build on Pre-TAPED I, and determine whether applying paper tape to the areas of the foot where blisters historically occur in endurance runners can prevent the incidence of friction blisters.
Detailed description
Participants will be ultra-endurance athletes competing in Racing the Planet's 250 mile/7 day 4 Desert events in 2014 (Jordan, Gobi, Madagascar, and Atacama. 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. Randomization will be conducted 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. The runner's normal sock/shoe system will be used to reflect natural wilderness conditions. 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 have tape applied to area(s) prone to blister on 1 foot, if no blister history, 1 area will be randomly assigned. The tape will be left on the selected foot until a blister or hot spot develops on either foot or the end of the race, whichever comes first. At that point, the study is over and the participant can continue or stop taping at their choice. If participants are prone to blisters or hot spots in particular areas, 1" paper tape applied to that site on trial foot. However, if the participant has no previous blister or hot spot experience, a site will be randomly assigned by picking a piece of paper out of a bag with the site written on a piece of paper (heel, toe, instep, head of 5th metatarsal). Therefore, a single participant can have more than 1 site on an individual foot.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paper Tape | Experimental | Device: Paper TapePaper tape will be applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any runner who are enrolled in an RTP 4 deserts event, All runners who are 18-75 years old All runners who speak or read English. The study will be enrolling only those who speak or read 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 researcher.
- The runner allergic to paper-tape.
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 TapeApplied to blister prone areas of the foot | Device | Paper Tape |
Primary outcome
Count of Participants With Any Foot Blister in Taped or Untaped Area of the Foot
Time frame: within 7 days of application of tape
Blister data were collected without regard to whether the foot was right or left.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27070112Lipman GS, Sharp LJ, Christensen M, Phillips C, DiTullio A, Dalton A, Ng P, Shangkuan J, Shea K, Krabak BJ. Paper Tape Prevents Foot Blisters: A Randomized Prevention Trial Assessing Paper Tape in Endurance Distances II (Pre-TAPED II). Clin J Sport Med. 2016 Sep;26(5):362-8. doi: 10.1097/JSM.0000000000000319.
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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, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paper Tape in people with Blister of Foot, run by Stanford University at 1 site 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 1 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 12 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 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 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 Any Foot Blister in Taped or Untaped Area of the Foot (time frame: within 7 days of application of tape). 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 NCT01945112, 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 12 Dec 2018.