<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/NCT03808181</url>
  </required_header>
  <id_info>
    <org_study_id>ChloraSolv 01</org_study_id>
    <nct_id>NCT03808181</nct_id>
  </id_info>
  <brief_title>An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds</brief_title>
  <official_title>An Open, Single-arm, Multi Centre Pilot Investigation to Evaluate the Debriding Effect of ChloraSolv® on Chronic Wounds, Covered With Devitalised Tissue, During Six Weeks Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RLS Global</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RLS Global</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this clinical investigation is to evaluate the debriding effect of&#xD;
      ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 58 subjects from at least two sites in Sweden will be included. Subjects&#xD;
      presented with lower leg ulcer, covered with devitalised tissue for 50% or more and being&#xD;
      candidate for cleansing, debridement/desloughing will be enrolled. Weekly application of&#xD;
      Investigational Product for 6 weeks. Follow-up for wound status evaluation after 12 weeks&#xD;
      from baseline. Total time in investigation is 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</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>The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 month) lower leg ulcer.</measure>
    <time_frame>6 weeks</time_frame>
    <description>The debriding effect of ChloraSolv® will be assessed by planimetry (photography) prior to and after each debridement. The photos will be sent for evaluation by an independent assessor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary objectives are to evaluate change of devitalised tissue, change in wound area, pain during treatment, condition of the wound, need for sharp debridement and overall evaluation of the product and safety parameters.</measure>
    <time_frame>12 weeks</time_frame>
    <description>The objectives to evaluate change of devitalised tissue and change in wound area will be assessed by planimetry (photography) prior to and after each debridement. The photos will be sent for evaluation by an independent assessor. Pain during treatment will be assessed by the patient using a Visual Analogue Scale (VAS) for pain. The condition of the wound, need for sharp debridement, overall evaluation of the product and safety parameters are assessed by the health care professional treating the patient and the information is collected in the Case Report Form (CRF)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Chronic Ulcer at Lower Leg</condition>
  <arm_group>
    <arm_group_label>Active treatment with ChloraSolv</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ChloraSolv</intervention_name>
    <description>Weekly application of ChloraSolv for 6 weeks</description>
    <arm_group_label>Active treatment with ChloraSolv</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Full skin ulcer at lower leg covered with devitalised tissue ≥50%&#xD;
&#xD;
          2. Candidate for cleansing, debridement/desloughing&#xD;
&#xD;
          3. Wound area ≥2 cm²&#xD;
&#xD;
          4. Male or female, 18 years of age and above&#xD;
&#xD;
          5. Able to read and understand the Patient Informed Consent and to provide meaningful&#xD;
             written informed consent&#xD;
&#xD;
          6. Able and willing to follow the Protocol requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Clinical signs of system progression infection with or without ostemyelitis&#xD;
&#xD;
          2. Wound located where treatment is not possible&#xD;
&#xD;
          3. Subjects not suitable for the investigation according to the investigator's judgment&#xD;
&#xD;
          4. Subjects included in other ongoing clinical investigation which could interfere with&#xD;
             this investigation, as judged by the investigator&#xD;
&#xD;
          5. Known allergy/hypersensitivity to any of the components of the investigational device&#xD;
&#xD;
          6. Pregnant or breast feeding women&#xD;
&#xD;
          7. Other significant medical condition that the investigator determines could interfere&#xD;
             with compliance or study assessments&#xD;
&#xD;
          8. Subjects with wounds of duration less than one month&#xD;
&#xD;
          9. Wound area greater than approximately 60 cm²&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Endocrinology Skåne University Hospital Malmö</name>
      <address>
        <city>Malmö</city>
        <state>Skåne</state>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Primary Care Center Tunafors</name>
      <address>
        <city>Eskilstuna</city>
        <state>Sörmland</state>
        <zip>63188</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wästerläkarna Primary Care Center</name>
      <address>
        <city>Göteborg</city>
        <state>Västra Frölunda</state>
        <zip>42677</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carlanderska Sjukhuset</name>
      <address>
        <city>Göteborg</city>
        <state>Västra Götaland</state>
        <zip>40545</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicinkliniken, Diabetescentrum, Sahlgrenska Universitetssjukhuset</name>
      <address>
        <city>Göteborg</city>
        <state>Västra Götaland</state>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Närhälsan Olskroken Primary Care Center</name>
      <address>
        <city>Göteborg</city>
        <state>Västra Götaland</state>
        <zip>41665</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hudmottagningen Skaraborgs Sjukhus</name>
      <address>
        <city>Skövde</city>
        <state>Västra Götaland</state>
        <zip>54185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept of Orthopaedic Surgery</name>
      <address>
        <city>Mölndal</city>
        <zip>43180</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sårcentrum Södersjukhuset Stockholm</name>
      <address>
        <city>Stockholm</city>
        <zip>11883</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03808181
org study id: ChloraSolv 01
nct id: NCT03808181
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this clinical investigation is to evaluate the debriding effect of
      ChloraSolv® on chronic (more than 1 moth) lower leg ulcer.
Approximately 58 subjects from at least two sites in Sweden will be included. Subjects
      presented with lower leg ulcer, covered with devitalised tissue for 50% or more and being
      candidate for cleansing, debridement/desloughing will be enrolled. Weekly application of
      Investigational Product for 6 weeks. Follow-up for wound status evaluation after 12 weeks
      from baseline. Total time in investigation is 12 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary objective of this clinical investigation is to evaluate the debriding effect of ChloraSolv® on chronic (more than 1 month) lower leg ulcer.
time frame: 6 weeks
description: The debriding effect of ChloraSolv® will be assessed by planimetry (photography) prior to and after each debridement. The photos will be sent for evaluation by an independent assessor.
measure: The secondary objectives are to evaluate change of devitalised tissue, change in wound area, pain during treatment, condition of the wound, need for sharp debridement and overall evaluation of the product and safety parameters.
time frame: 12 weeks
description: The objectives to evaluate change of devitalised tissue and change in wound area will be assessed by planimetry (photography) prior to and after each debridement. The photos will be sent for evaluation by an independent assessor. Pain during treatment will be assessed by the patient using a Visual Analogue Scale (VAS) for pain. The condition of the wound, need for sharp debridement, overall evaluation of the product and safety parameters are assessed by the health care professional treating the patient and the information is collected in the Case Report Form (CRF)
arm group label: Active treatment with ChloraSolv
arm group type: Other
description: Single arm
intervention type: Device
intervention name: ChloraSolv
description: Weekly application of ChloraSolv for 6 weeks
arm group label: Active treatment with ChloraSolv
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
sharing ipd: No