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

• 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: Stanford University
• Collaborator: Resurrection Medical Center
• Information provided by (Responsible Party): Grant S Lipman, Stanford University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, California

Stanford University

Stanford, California, United States, 94034

Sponsors and Collaborators

Stanford University

Resurrection Medical Center

Investigators

• Principal Investigator: Grant S Lipman, MD; Stanford University

More Information

Publications of Results:

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.

• Responsible Party: Grant S Lipman, Principal Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT01945112
• Other Study ID Numbers: 28548
• First Posted: September 18, 2013
• Results First Posted: May 16, 2017
• Last Update Posted: December 12, 2018
• Last Verified: November 2018

Additional relevant MeSH terms:

Blister; Skin Diseases, Vesiculobullous; Skin Diseases; Pathological Conditions, Anatomical