<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/NCT02184455</url>
  </required_header>
  <id_info>
    <org_study_id>DeCell-001</org_study_id>
    <nct_id>NCT02184455</nct_id>
  </id_info>
  <brief_title>Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment</brief_title>
  <official_title>A Feasibility Study of DermGEN Dermal Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Paul F. Gratzer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>DeCell Technologies Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical trial is to perform a limited pilot study to determine the&#xD;
      safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU).&#xD;
      This will be a one-arm prospective study. It is hypothesized that DermGEN treatment will&#xD;
      result in positive healing outcomes with no significant adverse effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a one-arm prospective study. This study in Halifax will be mirrored in one other&#xD;
      participating health care center in Toronto, Ontario, Canada with each centre anticipated to&#xD;
      enrol 5-10 patients for a total of 15-20 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">May 1, 2017</completion_date>
  <primary_completion_date type="Actual">May 1, 2017</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>Diabetic type I/II patients with chronic ulcer present</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Wound Area Reduction Compared to Baseline</measure>
    <time_frame>4 weeks</time_frame>
    <description>Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Complete Healing at Any Time Point</measure>
    <time_frame>20 weeks</time_frame>
    <description>Complete healing is defined as 100% epithelialization without drainage. Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Adverse Events</measure>
    <time_frame>20 weeks</time_frame>
    <description>Reporting the number of patients participating in the study having adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients that reported a reoccurrence of the ulcer in the same location after complete healing at 1 year post treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Wound Size Compared to Baseline</measure>
    <time_frame>20 weeks</time_frame>
    <description>Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100. Note 100% equals complete closure of the wound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Wound Area From Baseline</measure>
    <time_frame>12 Weeks</time_frame>
    <description>change in area of wound in percent from initial presentation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Diabetes Type I</condition>
  <condition>Diabetes Type II</condition>
  <arm_group>
    <arm_group_label>DermGEN Decellularized Dermal Matrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DermGEN</intervention_name>
    <description>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.</description>
    <arm_group_label>DermGEN Decellularized Dermal Matrix</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A subject will be considered eligible to participate in this study if each of the following&#xD;
        inclusion criteria is satisfied:&#xD;
&#xD;
          1. Patient with documented stable Type I or II diabetes (HbA1C &gt;7.0 within 1 month prior&#xD;
             to Day 0).&#xD;
&#xD;
          2. Patient's ulcer has been present for a minimum of 2 weeks as of Day 0.&#xD;
&#xD;
          3. Study ulcer has healed &lt;30% in size during the 2 weeks prior to Day 0.&#xD;
&#xD;
          4. Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study.&#xD;
&#xD;
          5. Ulcer extends through dermis and into subcutaneous tissue but without exposure of&#xD;
             muscle, tendon, bone or joint capsule.&#xD;
&#xD;
          6. Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy&#xD;
             vascular tissue suitable for skin grafting on Day 0.&#xD;
&#xD;
          7. Patient has adequate circulation to the foot as evidenced by palpable pulse or pulse&#xD;
             detectable with Doppler ultrasound, and lack of visible cyanosis in skin bordering the&#xD;
             ulcer.&#xD;
&#xD;
          8. Female patients are not pregnant at time of, or during study.&#xD;
&#xD;
          9. Patient and caregiver ready and willing to participate and comply with follow-up&#xD;
             regime.&#xD;
&#xD;
         10. Patient or legal representative has read and signed the Institutional Ethics Review&#xD;
             Board approved informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A subject will not be considered eligible to participate in this study if any one of the&#xD;
        following exclusion criteria is satisfied:&#xD;
&#xD;
          1. Evidence of gangrene on affected foot.&#xD;
&#xD;
          2. Ulcer is over Charcot deformity (fractures or dislocation).&#xD;
&#xD;
          3. Ulcer is non-diabetic in etiology.&#xD;
&#xD;
          4. Ulcer has tunnels or sinus tracts that cannot be completely debrided.&#xD;
&#xD;
          5. Medical condition(s) that in the Investigator's opinion make the patient inappropriate&#xD;
             for study&#xD;
&#xD;
          6. Patient has/had malignant disease not in remission for 5 years or more&#xD;
&#xD;
          7. Patient has acute or chronic hepatitis, cirrhosis, serum albumin &lt;2.0 gm/dL, or has&#xD;
             alkaline phosphatase or LDH at twice the normal upper limit&#xD;
&#xD;
          8. Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic&#xD;
             agents, or is anticipated to require such agents during study&#xD;
&#xD;
          9. Patient received radiation therapy within 30 days of Day 0 of study&#xD;
&#xD;
         10. Patient has AIDS or is infected with HIV&#xD;
&#xD;
         11. Patient has participated in another study using investigational drug(s) or device&#xD;
             within the previous 30 days&#xD;
&#xD;
         12. Obvious clinical signs and symptoms of ongoing cellulitis or osteomyelitis&#xD;
&#xD;
         13. Patient has any other condition which seriously compromises their ability to complete&#xD;
             the study&#xD;
&#xD;
         14. Patient has known allergies to antibiotics, such as penicillin and streptomycin&#xD;
&#xD;
         15. Patient has a history of bleeding disorder&#xD;
&#xD;
         16. Patient received elective osseous procedures to the study foot within 30 days prior to&#xD;
             screening visit, except that patients whose DFU overlies an area of treated&#xD;
             osteomyelitis may be included, providing there exists a suitable base for application&#xD;
             of the DermGEN.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Glazebrook, PhD,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Elizabeth II Health Sciences Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Center</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>June 4, 2019</results_first_submitted>
  <results_first_submitted_qc>August 8, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 16, 2019</results_first_posted>
  <last_update_submitted>September 13, 2019</last_update_submitted>
  <last_update_submitted_qc>September 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>DeCell Technologies Inc.</investigator_affiliation>
    <investigator_full_name>Dr. Paul F. Gratzer</investigator_full_name>
    <investigator_title>CEO</investigator_title>
  </responsible_party>
  <keyword>Diabetic</keyword>
  <keyword>Chronic Ulcer</keyword>
  <keyword>Wound Healing</keyword>
  <keyword>Leg</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 28, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT02184455/Prot_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at the Multi-disciplinary Leg Ulcer Clinic at the Queen Elizabeth II Hospital, Halifax, N.S. and Wound Care Clinic at St. Michael's Hospital, Toronto, O.N. The study was initiated on July 1st, 2016 and ended patient enrolment on March 31st, 2017.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>DermGEN Decellularized Dermal Matrix</title>
          <description>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.&#xD;
DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <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_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline population was the same as intervention population</population>
      <group_list>
        <group group_id="B1">
          <title>DermGEN Decellularized Dermal Matrix</title>
          <description>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.&#xD;
DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61" spread="13"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Wound Area Reduction Compared to Baseline</title>
        <description>Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DermGEN Decellularized Dermal Matrix</title>
            <description>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.&#xD;
DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Wound Area Reduction Compared to Baseline</title>
          <description>Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.</description>
          <units>percentage of wound closure</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Complete Healing at Any Time Point</title>
        <description>Complete healing is defined as 100% epithelialization without drainage. Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.</description>
        <time_frame>20 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DermGEN Decellularized Dermal Matrix</title>
            <description>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.&#xD;
DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Complete Healing at Any Time Point</title>
          <description>Complete healing is defined as 100% epithelialization without drainage. Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Adverse Events</title>
        <description>Reporting the number of patients participating in the study having adverse events</description>
        <time_frame>20 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DermGEN Decellularized Dermal Matrix</title>
            <description>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.&#xD;
DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Adverse Events</title>
          <description>Reporting the number of patients participating in the study having adverse events</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing</title>
        <description>Number of patients that reported a reoccurrence of the ulcer in the same location after complete healing at 1 year post treatment.</description>
        <time_frame>1 year</time_frame>
        <population>These are the number of patients that had their ulcer healed within the 20 weeks of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>DermGEN Decellularized Dermal Matrix</title>
            <description>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.&#xD;
DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing</title>
          <description>Number of patients that reported a reoccurrence of the ulcer in the same location after complete healing at 1 year post treatment.</description>
          <population>These are the number of patients that had their ulcer healed within the 20 weeks of the study.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Wound Size Compared to Baseline</title>
        <description>Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100. Note 100% equals complete closure of the wound.</description>
        <time_frame>20 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DermGEN Decellularized Dermal Matrix</title>
            <description>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.&#xD;
DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Wound Size Compared to Baseline</title>
          <description>Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100. Note 100% equals complete closure of the wound.</description>
          <units>percentage from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Wound Area From Baseline</title>
        <description>change in area of wound in percent from initial presentation</description>
        <time_frame>12 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DermGEN Decellularized Dermal Matrix</title>
            <description>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.&#xD;
DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Wound Area From Baseline</title>
          <description>change in area of wound in percent from initial presentation</description>
          <units>percentage of change from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected during the study and for up to 1 year post-treatment for all patients.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>DermGEN Decellularized Dermal Matrix</title>
          <description>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.&#xD;
DermGEN: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </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="0" subjects_at_risk="10"/>
              </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>
    <limitations_and_caveats>This study was a low numbered, one-arm, safety and feasibility study. No statistical analyses for superiority were intended nor attempted.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Paul F. Gratzer, CSO</name_or_title>
      <organization>DeCell Technolpogies Inc.</organization>
      <phone>902-223-2179</phone>
      <email>pfgratzer@decelltechnologies.com</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/NCT02184455
org study id: DeCell-001
nct id: NCT02184455
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this clinical trial is to perform a limited pilot study to determine the
      safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU).
      This will be a one-arm prospective study. It is hypothesized that DermGEN treatment will
      result in positive healing outcomes with no significant adverse effects.
This will be a one-arm prospective study. This study in Halifax will be mirrored in one other
      participating health care center in Toronto, Ontario, Canada with each centre anticipated to
      enrol 5-10 patients for a total of 15-20 patients.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Diabetic type I/II patients with chronic ulcer present
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Wound Area Reduction Compared to Baseline
time frame: 4 weeks
description: Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.
measure: Percentage of Patients With Complete Healing at Any Time Point
time frame: 20 weeks
description: Complete healing is defined as 100% epithelialization without drainage. Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.
measure: Number of Patients With Adverse Events
time frame: 20 weeks
description: Reporting the number of patients participating in the study having adverse events
measure: Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing
time frame: 1 year
description: Number of patients that reported a reoccurrence of the ulcer in the same location after complete healing at 1 year post treatment.
measure: Percent Change in Wound Size Compared to Baseline
time frame: 20 weeks
description: Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100. Note 100% equals complete closure of the wound.
measure: Percent Change in Wound Area From Baseline
time frame: 12 Weeks
description: change in area of wound in percent from initial presentation
arm group label: DermGEN Decellularized Dermal Matrix
arm group type: Experimental
description: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.
intervention type: Biological
intervention name: DermGEN
description: DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.
arm group label: DermGEN Decellularized Dermal Matrix
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Glazebrook, PhD,MD
role: Principal Investigator
affiliation: Queen Elizabeth II Health Sciences Center
facility: 
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: DeCell Technologies Inc.
investigator full name: Dr. Paul F. Gratzer
investigator title: CEO
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was a low numbered, one-arm, safety and feasibility study. No statistical analyses for superiority were intended nor attempted.
point of contact: 