Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II)
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|ClinicalTrials.gov Identifier: NCT01945112|
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : May 16, 2017
Last Update Posted : December 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Blister of Foot||Device: Paper Tape||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II)|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Paper Tape
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.
Device: Paper Tape
Applied to blister prone areas of the foot
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945112
|United States, California|
|Stanford, California, United States, 94034|
|Principal Investigator:||Grant S Lipman, MD||Stanford University|