A Phase 1 interventional study of Paper tape in Blister, sponsored by Stanford University. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-13.
Sponsored by Stanford University · Phase 1, Interventional, and Prevention
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.
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.
36 studies on the registry are indexed under Blister; 3 are open to participants now.
This study's enrollment of 136 is above the median of 65 across 24 interventional studies indexed under Blister.
Browse Blister studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
Procedure: Paper tape
Paper tape assigned to each participant's randomly selected foot.
Count of Participants With Blisters
Time frame: 1 week
| Milestone | All Participants |
|---|---|
| Started | 136 |
| Completed | 90 |
| Not completed | 46 |
| Participants | All Participants |
|---|---|
| Blisters on both feet | 8 |
| Blister on taped foot | 47 |
| Blister on untaped foot | 35 |
Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | — | 0/90 (0%) | 0/90 (0%) |
Per protocol, participants completing the primary outcome measure were analyzable for baseline characteristics.
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 40 ± 9.4 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 32 |
| Male | 58 |
The record gives a start of Apr 2010, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2017, 5 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.