Blister Eradication Looking at Impact of Experimental Versus Established Regimens (BELIEVER)

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.

Study Overview

• Status: Recruiting
• Conditions: Blister of Foot
• Intervention / Treatment: Other: Elastikon; Other: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick B Burns, MD; Phone Number: 9788663533; Email: pburns@stanford.edu
• Study Contact Backup: Name: Grant Lipman, MD; Phone Number: 4152909286; Email: gslipman@stanford.edu

Study Locations

• Chile
  • San Pedro de Atacama, Chile
    • Recruiting
    • Racing the Planet
    • Contact: Patrick B Burns, MD; Phone Number: 9788663533; Email: pburns@stanford.edu
• Mongolia
  • Ulaan Baatar, Mongolia
    • Recruiting
    • Racing the Planet
    • Contact: Patrick B Burns, MD; Phone Number: 9788663533; Email: pburns@stanford.edu
• Namibia
  • Windhoek, Namibia
    • Recruiting
    • Namib Desert
    • Contact: Patrick B Burns, MD; Phone Number: 9788663533; Email: pburns@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Elastikon - traditional; 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.	Other: Elastikon; 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.
Experimental: Rocktape - novel; 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	Other: Rocktape; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.; The blister treatment is a success as defined by:the blister treatment falls off and the subject has no pain and no blister reoccurrencethe blister treatment is removed by the subject and does not need to be replaced because the there is no pain or blister presentthe blister treatment stays on for the length of the study needing no intervention; The blister treatment is a failure as defined by:if the blister re-occursif the treated area has pain to the point that the blister treatment must be removed to evaluateif the subject removes the blister treatment and needs to be retreated.; The race has come to completion; The subject withdraws from the race or 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.

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Patrick B Burns, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2019
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: February 2, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Skin Diseases, Vesiculobullous; Blister
• Other Study ID Numbers: IRB-49612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No