<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/NCT02222454</url>
  </required_header>
  <id_info>
    <org_study_id>CL-K1002-P006</org_study_id>
    <nct_id>NCT02222454</nct_id>
  </id_info>
  <brief_title>Safety Evaluation of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers</brief_title>
  <official_title>A Prospective Case Series Evaluating the Safety of the KLOX BioPhotonic System in Stage II and III Pressure Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KLOX Technologies Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KLOX Technologies Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of these case series is to evaluate the safety and tolerability of the&#xD;
      KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with&#xD;
      stage II or III pressure ulcers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <primary_completion_date type="Actual">August 2015</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>Safety and tolerability of the KLOX BioPhotonic System in patients with stage II or III pressure ulcers.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Occurrence of adverse events, serious adverse events and incidents; pain assessment with Visual Analog Scale; clinical laboratory parameters; vital signs; physical examination; percentage of patients with clinical infection requiring systemic antimicrobial therapy; concomitant medications and treatments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optimal frequency of treatment with KLOX BioPhotonic System on stage II and III pressure ulcers.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Exploration of the optimal frequency of treatment with KLOX BioPhotonic System on stage II and III pressure ulcers, with dosing flexibility according to Investigator's clinical opinion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of complete wound closure.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to complete wound closure.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of wound breakdown.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound area reduction over time.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound volume reduction over time.</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Impact of treatment on Health-related quality of life.</measure>
    <time_frame>24 weeks</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Pressure Ulcers Stage II</condition>
  <condition>Pressure Ulcers Stage III</condition>
  <arm_group>
    <arm_group_label>KLOX BioPhotonic System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with KLOX BioPhotonic System in adjunction to Standard Of Care for pressure ulcers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>KLOX BioPhotonic System</intervention_name>
    <description>KLOX BioPhotonic System (Multi-LED Light and KLOX Photo Converter Wound Gel) will be administered until wound closure or for a maximum of 16 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for pressure ulcers.</description>
    <arm_group_label>KLOX BioPhotonic System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female 18 years of age and older;&#xD;
&#xD;
          -  The subject or legal guardian must have signed an informed consent form;&#xD;
&#xD;
          -  Female of child bearing potential must have a negative pregnancy test result at&#xD;
             Baseline and both male and female patients must be willing to adhere to a&#xD;
             medically-accepted birth control method during the course of the study;&#xD;
&#xD;
          -  Willingness to return for all study visits;&#xD;
&#xD;
          -  Stage II or III pressure ulcer (as per NPUAP Staging Guidelines), present for more&#xD;
             than 4 weeks (up to Screening visit), located in the ischial, trochanteric, coccygeal,&#xD;
             thoracic or abdominal regions. Lower extremity pressure ulcers, such as heel ulcers,&#xD;
             are acceptable provided that diabetic foot ulcers are ruled out if the patient has&#xD;
             diabetes. Surface dimensions of ulcer must be between 2 to 64 cm2 inclusive but&#xD;
             longest diameter must not exceed 10 cm. Depth must not exceed 5 cm;&#xD;
&#xD;
          -  Wound area has not changed by more than +/- 30% between Screening visit and Week&#xD;
             1/Visit 1 (before treatment).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pressure ulcer present for more than 18 months;&#xD;
&#xD;
          -  The ulcer to be treated is planned for operative debridement;&#xD;
&#xD;
          -  The ulcer has significant necrotic tissue (e.g., more than 20% of the ulcer area);&#xD;
&#xD;
          -  Major uncontrolled medical disorder(s) such as serious cardiovascular, renal, liver or&#xD;
             pulmonary disease, lupus, palliative care or sickle cell anemia;&#xD;
&#xD;
          -  Severe or significant hypoalbuminemia (albuminemia &lt; 30 g/L, and/or pre-albumin &lt; 5&#xD;
             mg/dL), or hypoproteinemia (proteinemia &lt; 55g/L);&#xD;
&#xD;
          -  Patient with moderate to severe anemia (Hb &lt; 90g/L);&#xD;
&#xD;
          -  Patient currently treated for an active malignant disease;&#xD;
&#xD;
          -  Patient with history of malignancy within the wound;&#xD;
&#xD;
          -  Patient with history of radiation therapy to the wound region;&#xD;
&#xD;
          -  Patient with prior diagnosis of active malignant disease who is less than 1 year&#xD;
             disease-free;&#xD;
&#xD;
          -  Patient with a known osteomyelitis or active cellulitis;&#xD;
&#xD;
          -  Patients that are immunosuppressed or on high dose chronic steroid use;&#xD;
&#xD;
          -  Patients on systemic corticosteroids (a completion of corticosteroid course at least&#xD;
             30 days prior to study enrolment is required);&#xD;
&#xD;
          -  Patient with active or systemic infection (note that the patient is however eligible&#xD;
             for re-screening after the systemic infection has subsided);&#xD;
&#xD;
          -  Patients with severely uncontrolled diabetes mellitus (defined as A1C &gt; 12%);&#xD;
&#xD;
          -  Dermatologic comorbid disease (e.g., cutis laxa or collagen vascular disease);&#xD;
&#xD;
          -  Active bleeding;&#xD;
&#xD;
          -  Pregnancy, or breast feeding;&#xD;
&#xD;
          -  Patients with bleeding diathesis;&#xD;
&#xD;
          -  Patients on Warfarin or IV Heparin;&#xD;
&#xD;
          -  The subject has any physical or psychiatric condition that in the Investigator's&#xD;
             opinion would warrant exclusion from the study or prevent the subject from completing&#xD;
             the study (e.g., severe morbid obesity, recent hip fracture, suspected non-compliance,&#xD;
             etc.);&#xD;
&#xD;
          -  Patients with ulcers from burns (from exposure to high heat), venous ulcers or&#xD;
             diabetic foot ulcers;&#xD;
&#xD;
          -  Concurrent disease or drugs known to induce severe photosensitivity of the skin, such&#xD;
             as porphyria;&#xD;
&#xD;
          -  Patient has received biological-based therapy in any wound within 3 months of&#xD;
             Screening;&#xD;
&#xD;
          -  Concurrent participation in another clinical trial that involves an investigational&#xD;
             drug or device that wound interfere with this study;&#xD;
&#xD;
          -  Previous participation in other interventional wound healing clinical investigation&#xD;
             within the 60 days prior to Screening visit.&#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>David Keast, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawton Research Institute, London, Ontario, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Calgary Center for Clinical Research</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's University</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 3N6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawton Health Research Institute</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6C 2R5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St-Jerome Medical Research Inc.</name>
      <address>
        <city>St-Jerome</city>
        <state>Quebec</state>
        <zip>J7Z 5T3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>February 22, 2016</last_update_submitted>
  <last_update_submitted_qc>February 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <!-- 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/NCT02222454
org study id: CL-K1002-P006
nct id: NCT02222454
lead sponsor: 
has dmc: No
The primary objective of these case series is to evaluate the safety and tolerability of the
      KLOX BioPhotonic System as adjunctive therapy to Standard Of Care (SOC) in patients with
      stage II or III pressure ulcers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability of the KLOX BioPhotonic System in patients with stage II or III pressure ulcers.
time frame: 24 weeks
description: Occurrence of adverse events, serious adverse events and incidents; pain assessment with Visual Analog Scale; clinical laboratory parameters; vital signs; physical examination; percentage of patients with clinical infection requiring systemic antimicrobial therapy; concomitant medications and treatments.
measure: Optimal frequency of treatment with KLOX BioPhotonic System on stage II and III pressure ulcers.
time frame: 24 weeks
description: Exploration of the optimal frequency of treatment with KLOX BioPhotonic System on stage II and III pressure ulcers, with dosing flexibility according to Investigator's clinical opinion.
measure: Rate of complete wound closure.
time frame: 24 weeks
measure: Time to complete wound closure.
time frame: 24 weeks
measure: Incidence of wound breakdown.
time frame: 24 weeks
measure: Wound area reduction over time.
time frame: 24 weeks
measure: Wound volume reduction over time.
time frame: 24 weeks
measure: Impact of treatment on Health-related quality of life.
time frame: 24 weeks
arm group label: KLOX BioPhotonic System
arm group type: Experimental
description: Treatment with KLOX BioPhotonic System in adjunction to Standard Of Care for pressure ulcers.
intervention type: Device
intervention name: KLOX BioPhotonic System
description: KLOX BioPhotonic System (Multi-LED Light and KLOX Photo Converter Wound Gel) will be administered until wound closure or for a maximum of 16 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for pressure ulcers.
arm group label: KLOX BioPhotonic System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Keast, Dr
role: Principal Investigator
affiliation: Lawton Research Institute, London, Ontario, Canada
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Pressure Ulcer
mesh term: Ulcer