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

Primary Purpose

Blister of Foot

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paper Tape
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blister of Foot

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paper Tape

Arm Description

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.

Outcomes

Primary Outcome Measures

Count of Participants With Any Foot Blister in Taped or Untaped Area of the Foot
Blister data were collected without regard to whether the foot was right or left.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2013
Last Updated
November 21, 2018
Sponsor
Stanford University
Collaborators
Resurrection Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01945112
Brief Title
Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II)
Official Title
Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Resurrection Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blister of Foot

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paper Tape
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Paper Tape
Intervention Description
Applied to blister prone areas of the foot
Primary Outcome Measure Information:
Title
Count of Participants With Any Foot Blister in Taped or Untaped Area of the Foot
Description
Blister data were collected without regard to whether the foot was right or left.
Time Frame
within 7 days of application of tape

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant S Lipman, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94034
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27070112
Citation
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.
Results Reference
result

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

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