BELIEVER

Trial ID or NCT#

NCT03835806

Status

not recruiting iconNOT RECRUITING

Purpose

The specific aim of this study is to evaluate whether RockTape has similar efficacy to Elastikon in the treatment of foot blisters in ultramarathon runners. Elastikon with paper tape and spray adhesive is a well-accepted means of blister treatment and has been used by medical staff at over 50 multi-stage ultramarathons around the world. RockTape is another commercially available product that has also been used by runners successfully to treat foot blisters. RockTape's adhesive qualities have a potential advantage over Elastikon, in that it does not require an additional adhesive substituting a level of complexity, weight, and cost for foot care. There have been no studies examining the efficacy of either agent for blister treatment. This randomized controlled trial will compare the traditional method of treating blisters with a multi-step approach of percutaneous drainage, paper tape, spray adhesive and then Elastikon to percutaneous drainage, paper tape and RockTape.

Official Title

Blister Eradication Looking at Impact of Experimental Versus Established Regimens

Eligibility Criteria

Ages Eligible for Study: 18 to 65
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. * The study enrollment period will run for approximately 7 days over 3 weeks throughout 2019 at Racing the Planet races in Namibia, Mongolia and Chile. All racers are potential subjects.
    1. Subjects will be enrolled when they present to the medical tent for the treatment of their first painful blister. The subject will be evaluated for exclusion criteria and the subject will be asked to select the most painful blister to be included in the study. All other blisters may be treated through traditional means and are not included in the study.
    2. Exclusion Criteria:
  2. * Blister exclusion criteria:
    1. 1. Toe blisters will be excluded because they are treated with paper tape only to avoid friction against neighboring toes and further blister formation. 2. Only intact blisters are included in this study as de-roofed blisters are treated differently. 3. Hemorrhagic blisters are excluded as they are often not amenable to percutaneous drainage given the increased risk in infection.
  3. If the most painful blister is a toe blister or a hemorrhagic blister, then the second most painful blister will be selected. If there is no second blister, the subject cannot be enrolled at this time.
Exclusion Criteria:
  1. Blister exclusion criteria:
View All Criteria
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Investigator(s)

Patrick B Burns
Emergency medicine doctor
Clinical Associate Professor, Emergency Medicine

Contact us to find out if this trial is right for you.

Contact

Patrick B Burns, MD
9788663533

View on ClinicalTrials.gov