<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/NCT03021811</url>
  </required_header>
  <id_info>
    <org_study_id>ORS-K1002-P001</org_study_id>
    <nct_id>NCT03021811</nct_id>
  </id_info>
  <brief_title>EUREKA Italy - Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management</brief_title>
  <official_title>EUREKA Italy - The Evaluation of Real-life Use of KLOX BioPhotonic System in Chronic Wounds Management: a Reproducibility Study</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>
      Multi-center, prospective, interventional, uncontrolled open-label study evaluating the&#xD;
      real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg&#xD;
      ulcers, diabetic foot ulcers, pressure ulcers).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Adverse events, Serious Adverse Events and Device Incidents</measure>
    <time_frame>Up to 34 weeks</time_frame>
    <description>Number of patients with adverse events, serious adverse events and device incidents.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of complete wound closure</measure>
    <time_frame>Up to 34 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound area reduction over time</measure>
    <time_frame>Up to 34 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to complete wound closure</measure>
    <time_frame>Up to 34 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of wound breakdown, following wound closure</measure>
    <time_frame>Up to 34 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of use by healthcare professionals (questionnaire)</measure>
    <time_frame>Up to 34 weeks</time_frame>
    <description>To collect feedback on the ease of use of the KLOX LumiHeal BioPhotonic System in the management of chronic wounds, from health care professional users.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of treatment on Health-related Quality of Life (CWIS questionnaire)</measure>
    <time_frame>Up to 34 weeks</time_frame>
    <description>To collect quality of life data in patients treated with the KLOX LumiHeal BioPhotonic System.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Venous Leg Ulcer</condition>
  <condition>Diabetic Foot Ulcer</condition>
  <condition>Pressure Ulcer</condition>
  <arm_group>
    <arm_group_label>LumiHeal</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>KLOX LumiHeal BioPhotonic System</intervention_name>
    <description>Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.</description>
    <arm_group_label>LumiHeal</arm_group_label>
    <other_name>LumiHeal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated written informed consent form;&#xD;
&#xD;
          -  Adult patient (at least 18 years old) having received a diagnosis of venous leg ulcer,&#xD;
             diabetic foot ulcer or pressure ulcer by the Investigator;&#xD;
&#xD;
          -  The treating physician (investigator) believes the KLOX LumiHeal BioPhotonic System&#xD;
             would be an appropriate option;&#xD;
&#xD;
          -  Both male and female patients must be willing to adhere to a medically-accepted birth&#xD;
             control method during the course of the study;&#xD;
&#xD;
          -  Willingness to comply with study requirements (visits, treatments, etc.).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female pregnant patient (by medical history or as ascertained by a pregnancy test);&#xD;
&#xD;
          -  Breast-feeding female patient;&#xD;
&#xD;
          -  Patients taking drugs/products (e.g., methotrexate, chemotherapy agents) or with&#xD;
             conditions (e.g., porphyria) known to induce severe photosensitivity reactions;&#xD;
&#xD;
          -  Patients with known skin hypersensitivity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</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>Diabetic Foot</mesh_term>
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>Foot Ulcer</mesh_term>
    <mesh_term>Leg Ulcer</mesh_term>
    <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/NCT03021811
org study id: ORS-K1002-P001
nct id: NCT03021811
lead sponsor: 
has dmc: No
Multi-center, prospective, interventional, uncontrolled open-label study evaluating the
      real-life use of KLOX LumiHeal BioPhotonic System in chronic wounds management (venous leg
      ulcers, diabetic foot ulcers, pressure ulcers).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events, Serious Adverse Events and Device Incidents
time frame: Up to 34 weeks
description: Number of patients with adverse events, serious adverse events and device incidents.
measure: Rate of complete wound closure
time frame: Up to 34 weeks
measure: Wound area reduction over time
time frame: Up to 34 weeks
measure: Time to complete wound closure
time frame: Up to 34 weeks
measure: Incidence of wound breakdown, following wound closure
time frame: Up to 34 weeks
measure: Ease of use by healthcare professionals (questionnaire)
time frame: Up to 34 weeks
description: To collect feedback on the ease of use of the KLOX LumiHeal BioPhotonic System in the management of chronic wounds, from health care professional users.
measure: Impact of treatment on Health-related Quality of Life (CWIS questionnaire)
time frame: Up to 34 weeks
description: To collect quality of life data in patients treated with the KLOX LumiHeal BioPhotonic System.
arm group label: LumiHeal
arm group type: Other
description: Treatment of chronic wounds with KLOX LumiHeal BioPhotonic System
intervention type: Device
intervention name: KLOX LumiHeal BioPhotonic System
description: Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.
arm group label: LumiHeal
other name: LumiHeal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Varicose Ulcer
mesh term: Foot Ulcer
mesh term: Leg Ulcer
mesh term: Pressure Ulcer
mesh term: Ulcer