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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01945112
Other study ID # 28548
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2014
Est. completion date July 2015

Study information

Verified date November 2018
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Paper Tape
Applied to blister prone areas of the foot

Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University Resurrection Medical Center

Country where clinical trial is conducted

United States, 

References & 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. 2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05086640 - Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners N/A
Recruiting NCT05071651 - Epidemiological Characteristics and Prevention Methods of Blisters in Ultra-trail Runners
Recruiting NCT03835806 - Blister Eradication Looking at Impact of Experimental Versus Established Regimens N/A