<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/NCT01716169</url>
  </required_header>
  <id_info>
    <org_study_id>24915</org_study_id>
    <nct_id>NCT01716169</nct_id>
  </id_info>
  <brief_title>Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care</brief_title>
  <official_title>Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the effectiveness of Helicoll (a collagen wound&#xD;
      dressing) in treating chronic and non-chronic wounds of recessive dystrophic epidermolysis&#xD;
      bullosa (RDEB) patients. Helicoll will be compared to standard wound dressings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Wound Surface Area Change From Baseline to Week 8</measure>
    <time_frame>Baseline and Week 8</time_frame>
    <description>Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Epidermolysis Bullosa Dystrophica</condition>
  <condition>Epidermolysis Bullosa</condition>
  <arm_group>
    <arm_group_label>Helicoll</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Helicoll will be applied to one chronic wound (approximately 6 months or more duration).&#xD;
Wound designations of &quot;control&quot; or &quot;Helicoll&quot; were placed in a sealed envelope prior to study start. When a subject was enrolled, wounds were identified as &quot;A&quot; or &quot;B&quot;. Then the envelope was opened which designated whether A or B would receive control or Helicoll.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Helicoll</intervention_name>
    <description>Helicoll Collagen I Wound Dressing</description>
    <arm_group_label>Helicoll</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard of Care Dressings</intervention_name>
    <description>Standard of Care wound dressings (e.g. Vaseline gauze)</description>
    <arm_group_label>Helicoll</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Written consent must be obtained from subjects over age 18, or from a parent or&#xD;
             legally authorized representative if subject is under 18. Assent will be obtained from&#xD;
             subjects age 7 - 17.&#xD;
&#xD;
          2. Subjects with a clinical diagnosis of RDEB by a dermatologist.&#xD;
&#xD;
          3. Have at least three target wounds that meet the following criteria:&#xD;
&#xD;
               -  One chronic wound, of approximately 6 months or more duration. If the subject has&#xD;
                  an additional chronic wound of similar size and duration, this additional wound&#xD;
                  will be treated with standard dressings and followed in the study. A wound in an&#xD;
                  area that consistently heals and then breaks down again will be considered a&#xD;
                  chronic wound.&#xD;
&#xD;
               -  Two non-chronic wounds, of approximately 3 months or less duration, of similar&#xD;
                  size, and able to be dressed separately. Both wounds should have approximately&#xD;
                  the same duration.&#xD;
&#xD;
             All wounds must be:&#xD;
&#xD;
               -  Open, and not scabbed or crusted over&#xD;
&#xD;
               -  Not actively infected&#xD;
&#xD;
               -  Not requiring surgical intervention&#xD;
&#xD;
          4. A parent or legally authorized representative must be willing and able to ensure&#xD;
             subject is present for all required study visits (for minor subjects).&#xD;
&#xD;
          5. The subject or caregiver (or a parent or legally authorized representative for&#xD;
             subjects under 18) must be able to follow instructions.&#xD;
&#xD;
          6. Subject must be age 7 or older.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Inability to travel to Stanford for study visits.&#xD;
&#xD;
          2. Complicating illness as determined by study investigators to be exclusionary including&#xD;
             any infection requiring systemic antibiotics.&#xD;
&#xD;
          3. Presence or history of squamous cell carcinoma at target wound site.&#xD;
&#xD;
          4. Known bovine (cow) or ovine (sheep) sensitivity.&#xD;
&#xD;
          5. Therapy with an investigational agent during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alfred Lane, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>May 22, 2015</results_first_submitted>
  <results_first_submitted_qc>April 1, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 5, 2016</results_first_posted>
  <last_update_submitted>April 1, 2016</last_update_submitted>
  <last_update_submitted_qc>April 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Alfred Lane</investigator_full_name>
    <investigator_title>Professor of Dermatology and Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epidermolysis Bullosa</mesh_term>
    <mesh_term>Epidermolysis Bullosa Dystrophica</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment from EB Clinic patients, organization website</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Helicoll - Chronic Wound</title>
          <description>Helicoll will be applied to one chronic wound (approximately 6 months or more duration)&#xD;
Helicoll: Helicoll Collagen I Wound Dressing</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Standard of Care Dressings Used</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>inconsistent dressing application</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Helicoll - Chronic Wound</title>
          <description>Helicoll will be applied to one chronic wound (approximately 6 months or more duration)&#xD;
Helicoll: Helicoll Collagen I Wound Dressing</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.6" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Wound Surface Area Change From Baseline to Week 8</title>
        <description>Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.</description>
        <time_frame>Baseline and Week 8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Helicoll - Chronic Wound</title>
            <description>Helicoll will be applied to one chronic wound (approximately 6 months or more duration)&#xD;
Helicoll: Helicoll Collagen I Wound Dressing</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care Dressing - Chronic Wound</title>
            <description>Standard of Care dressings will be applied to one chronic wound</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Wound Surface Area Change From Baseline to Week 8</title>
          <description>Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.</description>
          <units>percentage of wound surface area</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-63" lower_limit="-99.1" upper_limit="-26.9"/>
                    <measurement group_id="O2" value="-8.1" lower_limit="-34.4" upper_limit="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Helicoll - Chronic Wound</title>
          <description>Helicoll will be applied to one chronic wound (approximately 6 months or more duration)&#xD;
Helicoll: Helicoll Collagen I Wound Dressing</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care - Chronic Wound</title>
          <description>Standard of Care wound dressings (e.g. Vaseline gauze) will be applied to one chronic wound (of approximately 6 months duration) if the subject has more than one chronic wound of approximately the same size and duration as Helicoll chronic wound.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Alfred Lane</name_or_title>
      <organization>Stanford School of Medicine</organization>
      <phone>650 721 7166</phone>
      <email>atlane@stanford.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01716169
org study id: 24915
nct id: NCT01716169
lead sponsor: 
has dmc: No
The purpose of this study is to test the effectiveness of Helicoll (a collagen wound
      dressing) in treating chronic and non-chronic wounds of recessive dystrophic epidermolysis
      bullosa (RDEB) patients. Helicoll will be compared to standard wound dressings.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Wound Surface Area Change From Baseline to Week 8
time frame: Baseline and Week 8
description: Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.
arm group label: Helicoll
arm group type: Experimental
description: Helicoll will be applied to one chronic wound (approximately 6 months or more duration).
Wound designations of "control" or "Helicoll" were placed in a sealed envelope prior to study start. When a subject was enrolled, wounds were identified as "A" or "B". Then the envelope was opened which designated whether A or B would receive control or Helicoll.
intervention type: Device
intervention name: Helicoll
description: Helicoll Collagen I Wound Dressing
arm group label: Helicoll
intervention type: Device
intervention name: Standard of Care Dressings
description: Standard of Care wound dressings (e.g. Vaseline gauze)
arm group label: Helicoll
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Alfred Lane, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Alfred Lane
investigator title: Professor of Dermatology and Pediatrics
mesh term: Epidermolysis Bullosa
mesh term: Epidermolysis Bullosa Dystrophica
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 