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Prevention Trial Assessing Paper-Tape in Endurance Distances (PreTAPED)

Primary Purpose

Blister

Status
Completed
Phase
Phase 1
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

Eligibility Criteria

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

Inclusion Criteria:

  • All runners who are enrolled in an RTP 4 deserts event,
  • All runners who are 18-75 years old, and
  • All runners who speak English. The study will be enrolling only those who speak 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 study physician.
  • The runner has a pre-existing blistering condition.

Sites / Locations

  • University of California Davis
  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants

Arm Description

Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.

Outcomes

Primary Outcome Measures

Count of Participants With Blisters

Secondary Outcome Measures

Full Information

First Posted
May 7, 2010
Last Updated
November 21, 2018
Sponsor
Stanford University
Collaborators
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01120808
Brief Title
Prevention Trial Assessing Paper-Tape in Endurance Distances (PreTAPED)
Official Title
Prevention Trial Assessing Paper-Tape in Endurance Distances (PreTAPED)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
University of California, Davis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Participants
Arm Type
Experimental
Arm Description
Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
Intervention Type
Procedure
Intervention Name(s)
Paper tape
Intervention Description
Paper tape assigned to each participant's randomly selected foot.
Primary Outcome Measure Information:
Title
Count of Participants With Blisters
Time Frame
1 week

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: All runners who are enrolled in an RTP 4 deserts event, All runners who are 18-75 years old, and All runners who speak English. The study will be enrolling only those who speak 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 study physician. The runner has a pre-existing blistering condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant S Lipman
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25443754
Citation
Lipman GS, Ellis MA, Lewis EJ, Waite BL, Lissoway J, Chan GK, Krabak BJ. A prospective randomized blister prevention trial assessing paper tape in endurance distances (Pre-TAPED). Wilderness Environ Med. 2014 Dec;25(4):457-61. doi: 10.1016/j.wem.2014.06.013. Epub 2014 Oct 31.
Results Reference
result

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Prevention Trial Assessing Paper-Tape in Endurance Distances (PreTAPED)

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