<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/NCT02222467</url>
  </required_header>
  <id_info>
    <org_study_id>CL-K1002-P008</org_study_id>
    <nct_id>NCT02222467</nct_id>
  </id_info>
  <brief_title>Safety Evaluation of the KLOX BioPhotonic System in Venous Leg Ulcers</brief_title>
  <official_title>A Prospective Case Series Evaluating the Safety of the KLOX BioPhotonic System in Venous Leg 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;
      venous leg ulcers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">April 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 venous leg 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 venous leg ulcers.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Exploration of the optimal frequency of treatment with KLOX BioPhotonic System on venous leg 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">10</enrollment>
  <condition>Venous Leg Ulcers</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 venous leg 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 venous leg 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;
          -  Proven venous leg ulcer, clinically defined and confirmed by duplex, refilling time or&#xD;
             venous hypertension;&#xD;
&#xD;
          -  Open venous leg ulcer present for more than 4 weeks prior to study entry&#xD;
             (Screening/Visit 1);&#xD;
&#xD;
          -  Ulcer area between 5 and 100 cm2 inclusive, with a maximum depth of 1 cm. The maximum&#xD;
             diameter of the wound must not exceed 10 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;
          -  Adequate arterial blood perfusion (ABI (ankle brachial index) between 0.7 and 1.3,&#xD;
             inclusive).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Venous leg ulcer present for more than 12 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;
          -  Successful revascularization surgery of the leg with the ulcer to be treated less than&#xD;
             8 weeks prior to Screening;&#xD;
&#xD;
          -  Patients with severely uncontrolled diabetes mellitus (defined as A1C &gt; 12%);&#xD;
&#xD;
          -  Raynaud disease or other severe peripheral microvascular disease;&#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), pressure 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>Andreas Nikolis, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Victoria Park MediSpa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre de Medecine Integrative et Evolutive</name>
      <address>
        <city>Brossard</city>
        <state>Quebec</state>
        <zip>J4Z 1A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Q&amp;T Research Chicoutimi</name>
      <address>
        <city>Chicoutimi</city>
        <state>Quebec</state>
        <zip>G7H 7Y8</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>
    <facility>
      <name>Victoria Park MediSpa</name>
      <address>
        <city>Westmount</city>
        <state>Quebec</state>
        <zip>H3Z 1C3</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>Varicose Ulcer</mesh_term>
    <mesh_term>Leg 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/NCT02222467
org study id: CL-K1002-P008
nct id: NCT02222467
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
      venous leg 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 venous leg 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 venous leg ulcers.
time frame: 24 weeks
description: Exploration of the optimal frequency of treatment with KLOX BioPhotonic System on venous leg 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 venous leg 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 venous leg ulcers.
arm group label: Klox BioPhotonic System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Nikolis, Dr
role: Principal Investigator
affiliation: Victoria Park MediSpa
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Varicose Ulcer
mesh term: Leg Ulcer
mesh term: Ulcer