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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elastikon - traditional | Active Comparator | The participant will be randomized to a treatment arm according to their racing bib number. Even bib numbers will be in the Elastikon treatment arm. The researcher will evaluate the blister and treat according to treatment arm with the following blister treatment device intervention: the blister will be prepped per routine, drained, covered with paper tape, sprayed with adhesive spray and then covered with Elastikon. |
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| Rocktape - novel | Experimental | The participant will be randomized to a treatment arm according to their racing bib number. Odd bib numbers will be in the Rocktape treatment arm. The researcher will evaluate the blister and treat according to treatment arm with the following blister treatment device intervention: the blister will be prepped per routine, drained, covered with paper tape and then covered with Rocktape |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elastikon | Other | 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 which is our traditional blister treatment approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success | The subject's involvement in the study will end in one of the following situations and the researcher will fill out the appropriate data sheet at the time of the subject's departure from the study.
| 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. |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick B Burns, MD | Contact | 9788663533 | pburns@stanford.edu | |
| Grant Lipman, MD | Contact | 4152909286 | gslipman@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patrick B Burns, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Racing the Planet | Recruiting | San Pedro de Atacama | Chile |
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This is a randomized control trial looking at a novel blister treatment intervention versus a traditional model.
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The treatments are visually dissimilar, therefore blinding for the investigator and subject is not possible.
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| Rocktape | Other | This randomized controlled trial will compare the traditional method of treating blisters with a multi-step approach of percutaneous drainage, paper tape and then Rocktape which is our novel blister treatment approach. |
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| Racing the Planet | Recruiting | Ulaanbaatar | Mongolia |
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| Namib Desert | Recruiting | Windhoek | Namibia |
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