Prevention Trial Assessing Paper-Tape in Endurance Distances II (Pre-TAPED II)
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2013
CompletedFirst Posted
Study publicly available on registry
September 18, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
May 16, 2017
CompletedDecember 12, 2018
November 1, 2018
1.4 years
September 13, 2013
July 23, 2016
November 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
within 7 days of application of tape
Study Arms (1)
Paper Tape
EXPERIMENTALPaper 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Resurrection Medical Centercollaborator
Study Sites (1)
Stanford University
Stanford, California, 94034, United States
Related Publications (1)
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.
PMID: 27070112RESULT
Results Point of Contact
- Title
- Grant Lipman
- Organization
- Stanford Department of Emergency Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Grant S Lipman, MD
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 13, 2013
First Posted
September 18, 2013
Study Start
February 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
December 12, 2018
Results First Posted
May 16, 2017
Record last verified: 2018-11