Prevention Trial Assessing Paper-Tape in Endurance Distances (PreTAPED)
Condition: Blister
MeSH terms: Blister
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): Paper tape
Intervention type(s): Procedure
Intervention description(s): Paper tape assigned to each participant's randomly selected foot.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention