Clinical trial NCT03835806: Blister Eradication Looking at Impact of Experimental Versus Established Regimens
Official title: Blister Eradication Looking at Impact of Experimental Versus Established Regimens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blister of Foot
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized control trial looking at a novel blister treatment intervention versus a traditional model.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Friction foot blisters are one of the most common injuries encountered by hikers and runners(1) with incidence as high as 39% in marathoners(2). In adventure races it is the most commonly reported injury(3) and in expedition length ultramarathons, blisters account for nearly 74% of medical visits(4). While most blisters are of minor medical significance, they can impair concentration, decrease athletic performance, and can be potentially debilitating.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Exclusion Criteria:

* Blister exclusion criteria:

  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.

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.

Primary outcomes:
measure: Treatment success
timeFrame: Data will be collected during the 1 week ultramarathon in austere conditions until study completion, usually 3-5 days. This will be conducted over 3 separate races.
Secondary outcomes:
Other outcomes:
Locations:
city: San Pedro de Atacama
country: Chile
facility: Racing the Planet
city: Ulaan Baatar
country: Mongolia
facility: Racing the Planet
city: Windhoek
country: Namibia
facility: Namib Desert
Study officials:
affiliation: Stanford University
name: Patrick B Burns, MD
role: PRINCIPAL_INVESTIGATOR
References: