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Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01945112
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : May 16, 2017
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
Resurrection Medical Center
Information provided by (Responsible Party):
Grant S Lipman, Stanford University

Brief 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%. 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.

Condition or disease Intervention/treatment Phase
Blister of Foot Device: Paper Tape Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.


Information from the National Library of Medicine

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


Locations
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United States, California
Stanford University
Stanford, California, United States, 94034
Sponsors and Collaborators
Stanford University
Resurrection Medical Center
Investigators
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Principal Investigator: Grant S Lipman, MD Stanford University
Publications of Results:
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Responsible Party: Grant S Lipman, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01945112    
Other Study ID Numbers: 28548
First Posted: September 18, 2013    Key Record Dates
Results First Posted: May 16, 2017
Last Update Posted: December 12, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Blister
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical