<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03835806</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-49612</org_study_id>
    <nct_id>NCT03835806</nct_id>
  </id_info>
  <brief_title>Blister Eradication Looking at Impact of Experimental Versus Established Regimens</brief_title>
  <acronym>BELIEVER</acronym>
  <official_title>Blister Eradication Looking at Impact of Experimental Versus Established Regimens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aim of this study is to evaluate whether RockTape has similar efficacy to&#xD;
      Elastikon in the treatment of foot blisters in ultramarathon runners. Elastikon with paper&#xD;
      tape and spray adhesive is a well-accepted means of blister treatment and has been used by&#xD;
      medical staff at over 50 multi-stage ultramarathons around the world. RockTape is another&#xD;
      commercially available product that has also been used by runners successfully to treat foot&#xD;
      blisters. RockTape's adhesive qualities have a potential advantage over Elastikon, in that it&#xD;
      does not require an additional adhesive substituting a level of complexity, weight, and cost&#xD;
      for foot care. There have been no studies examining the efficacy of either agent for blister&#xD;
      treatment.&#xD;
&#xD;
      This randomized controlled trial will compare the traditional method of treating blisters&#xD;
      with a multi-step approach of percutaneous drainage, paper tape, spray adhesive and then&#xD;
      Elastikon to percutaneous drainage, paper tape and RockTape.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Friction foot blisters are one of the most common injuries encountered by hikers and&#xD;
      runners(1) with incidence as high as 39% in marathoners(2). In adventure races it is the most&#xD;
      commonly reported injury(3) and in expedition length ultramarathons, blisters account for&#xD;
      nearly 74% of medical visits(4). While most blisters are of minor medical significance, they&#xD;
      can impair concentration, decrease athletic performance, and can be potentially debilitating.&#xD;
&#xD;
      The specific aim of this study is to evaluate whether RockTape has similar efficacy to&#xD;
      Elastikon in the treatment of foot blisters in ultramarathon runners. Elastikon with paper&#xD;
      tape and spray adhesive is a well-accepted means of blister treatment and has been used by&#xD;
      medical staff at over 50 multi-stage ultramarathons around the world. RockTape is another&#xD;
      commercially available product that has also been used by runners successfully to treat foot&#xD;
      blisters. RockTape's adhesive qualities have a potential advantage over Elastikon, in that it&#xD;
      does not require an additional adhesive substituting a level of complexity, weight, and cost&#xD;
      for foot care. There have been no studies examining the efficacy of either agent for blister&#xD;
      treatment.&#xD;
&#xD;
      This randomized controlled trial will compare the traditional method of treating blisters&#xD;
      with a multi-step approach of percutaneous drainage, paper tape, spray adhesive and then&#xD;
      Elastikon to percutaneous drainage, paper tape and RockTape.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 27, 2019</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a randomized control trial looking at a novel blister treatment intervention versus a traditional model.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The treatments are visually dissimilar, therefore blinding for the investigator and subject is not possible.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment success</measure>
    <time_frame>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.</time_frame>
    <description>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.&#xD;
The blister treatment is a success as defined by:&#xD;
the blister treatment falls off and the subject has no pain and no blister reoccurrence&#xD;
the blister treatment is removed by the subject and does not need to be replaced because the there is no pain or blister present&#xD;
the blister treatment stays on for the length of the study needing no intervention&#xD;
The blister treatment is a failure as defined by:&#xD;
if the blister re-occurs&#xD;
if the treated area has pain to the point that the blister treatment must be removed to evaluate&#xD;
if the subject removes the blister treatment and needs to be retreated.&#xD;
The race has come to completion&#xD;
The subject withdraws from the race or the study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Blister of Foot</condition>
  <arm_group>
    <arm_group_label>Elastikon - traditional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rocktape - novel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Elastikon</intervention_name>
    <description>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.</description>
    <arm_group_label>Elastikon - traditional</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rocktape</intervention_name>
    <description>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.</description>
    <arm_group_label>Rocktape - novel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study enrollment period will run for approximately 7 days over 3 weeks throughout&#xD;
             2019 at Racing the Planet races in Namibia, Mongolia and Chile. All racers are&#xD;
             potential subjects.&#xD;
&#xD;
        Subjects will be enrolled when they present to the medical tent for the treatment of their&#xD;
        first painful blister. The subject will be evaluated for exclusion criteria and the subject&#xD;
        will be asked to select the most painful blister to be included in the study. All other&#xD;
        blisters may be treated through traditional means and are not included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blister exclusion criteria:&#xD;
&#xD;
               1. Toe blisters will be excluded because they are treated with paper tape only to&#xD;
                  avoid friction against neighboring toes and further blister formation.&#xD;
&#xD;
               2. Only intact blisters are included in this study as de-roofed blisters are treated&#xD;
                  differently.&#xD;
&#xD;
               3. Hemorrhagic blisters are excluded as they are often not amenable to percutaneous&#xD;
                  drainage given the increased risk in infection.&#xD;
&#xD;
        If the most painful blister is a toe blister or a hemorrhagic blister, then the second most&#xD;
        painful blister will be selected. If there is no second blister, the subject cannot be&#xD;
        enrolled at this time.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick B Burns, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick B Burns, MD</last_name>
    <phone>9788663533</phone>
    <email>pburns@stanford.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Grant Lipman, MD</last_name>
    <phone>4152909286</phone>
    <email>gslipman@stanford.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Racing the Planet</name>
      <address>
        <city>San Pedro de Atacama</city>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick B Burns, MD</last_name>
      <phone>9788663533</phone>
      <email>pburns@stanford.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Racing the Planet</name>
      <address>
        <city>Ulaan Baatar</city>
        <country>Mongolia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick B Burns, MD</last_name>
      <phone>9788663533</phone>
      <email>pburns@stanford.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Namib Desert</name>
      <address>
        <city>Windhoek</city>
        <country>Namibia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick B Burns, MD</last_name>
      <phone>9788663533</phone>
      <email>pburns@stanford.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>Chile</country>
    <country>Mongolia</country>
    <country>Namibia</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Patrick B Burns</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blister</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03835806
org study id: IRB-49612
nct id: NCT03835806
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized control trial looking at a novel blister treatment intervention versus a traditional model.
primary purpose: Treatment
masking: None (Open Label)
masking description: The treatments are visually dissimilar, therefore blinding for the investigator and subject is not possible.
measure: Treatment success
time frame: 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.
description: 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 reoccurrence
the blister treatment is removed by the subject and does not need to be replaced because the there is no pain or blister present
the 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-occurs
if the treated area has pain to the point that the blister treatment must be removed to evaluate
if 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.
arm group label: Elastikon - traditional
arm group type: Active Comparator
description: 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.
arm group label: Rocktape - novel
arm group type: Experimental
description: 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
intervention type: Other
intervention name: Elastikon
description: 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.
arm group label: Elastikon - traditional
intervention type: Other
intervention name: Rocktape
description: 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.
arm group label: Rocktape - novel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick B Burns, MD
role: Principal Investigator
affiliation: Stanford University
last name: Patrick B Burns, MD
phone: 9788663533
email: pburns@stanford.edu
last name: Grant Lipman, MD
phone: 4152909286
email: gslipman@stanford.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Chile
country: Mongolia
country: Namibia
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Patrick B Burns
investigator title: Clinical Assistant Professor
mesh term: Blister
sharing ipd: No