NCT01120808

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 11, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

March 24, 2017

Completed
Last Updated

December 13, 2018

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

May 7, 2010

Results QC Date

July 23, 2016

Last Update Submit

November 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Count of Participants With Blisters

    1 week

Study Arms (1)

All Participants

EXPERIMENTAL

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

Procedure: Paper tape

Interventions

Paper tapePROCEDURE

Paper tape assigned to each participant's randomly selected foot.

All Participants

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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 study physician.
  • The runner has a pre-existing blistering condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California Davis

Davis, California, 95616, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Blister

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Grant Lipman
Organization
Stanford Department of Emergency Medicine

Study Officials

  • Grant S Lipman

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

May 7, 2010

First Posted

May 11, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 13, 2018

Results First Posted

March 24, 2017

Record last verified: 2018-11

Locations