xml: <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/NCT05974228</url>
    </required_header>
    <id_info>
      <org_study_id>Long2023-CW-Bioglass</org_study_id>
      <nct_id>NCT05974228</nct_id>
    </id_info>
    <brief_title>Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage：a Randomized Controlled Trial</brief_title>
    <official_title>Bioglass Wound Dressing in Treatment of Chronic Wound in Different Stage：a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Yunfeng Li</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking University Third Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this randomized control trial is to test the efficacy and safety of a bioglass&#xD;
        wound dressing in patients with chronic wound in different stages. The main question it aims&#xD;
        to answer are:&#xD;
  &#xD;
          -  Whether the bioglass wound dressing have better efficacy and safety than blank control&#xD;
             in treatment of chronic wound in necrosis stable stage？&#xD;
  &#xD;
          -  Whether the bioglass wound dressing have better efficacy and safety than blank control&#xD;
             in treatment of chronic wound in granulation growth stage？ Participants will be assigned&#xD;
             with a 1:1 ratio into intervention group and control group.&#xD;
  &#xD;
        Participants of intervention group will receive bioglass wound dressing in addition with&#xD;
        clinical optimal treatment plan. Participants of control group will only receive clinical&#xD;
        optimal treatment plan.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>2-week reduction rate of wound area</measure>
      <time_frame>2-week</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>2-week wound healing rate</measure>
      <time_frame>2-week</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Chronic Wound</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Bioactive glass wound dressing</intervention_name>
      <description>Bioactive glass wound dressing is a dressing covered on the wound bed</description>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The patient is aged 18-80 years old;&#xD;
  &#xD;
            2. Ulcerative wounds;&#xD;
  &#xD;
            3. In the stage of stable necrosis or granulation growth;&#xD;
  &#xD;
            4. Voluntarily participate in this study and sign an informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock,&#xD;
               and respiratory failure have not been corrected yet;&#xD;
  &#xD;
            2. Uncontrolled blood glucose, Glucose test#Fasting blood sugar&gt;15mmol/L, Glycated&#xD;
               hemoglobin&gt;12%;&#xD;
  &#xD;
            3. There is active bleeding inside the wound, and routine basic treatment plans cannot be&#xD;
               implemented;&#xD;
  &#xD;
            4. Serum albumin &lt; 20 g/L; Hemoglobin&lt;60 g/L; Platelets&lt;50 × 10^9/L;&#xD;
  &#xD;
            5. Spreading infection status, currently or about to be treated with antibiotics;&#xD;
  &#xD;
            6. Patients with advanced malignant tumors;&#xD;
  &#xD;
            7. Active period of autoimmune diseases;&#xD;
  &#xD;
            8. Previous allergies to bioactive glass ointment dressings (self originating);&#xD;
  &#xD;
            9. The patient is unable to cooperate or has mental disorders;&#xD;
  &#xD;
           10. According to the judgment of the researcher, the subject has a clear reason that&#xD;
               cannot be removed and affects wound healing, which is not suitable for this study or&#xD;
               cannot comply with the requirements of this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University Third Hospital</investigator_affiliation>
      <investigator_full_name>Long Zhang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Chronic wound</keyword>
    <keyword>Bioactive glass</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974228
  org study id: Long2023-CW-Bioglass
  nct id: NCT05974228
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized control trial is to test the efficacy and safety of a bioglass
        wound dressing in patients with chronic wound in different stages. The main question it aims
        to answer are:
  
          -  Whether the bioglass wound dressing have better efficacy and safety than blank control
             in treatment of chronic wound in necrosis stable stage？
  
          -  Whether the bioglass wound dressing have better efficacy and safety than blank control
             in treatment of chronic wound in granulation growth stage？ Participants will be assigned
             with a 1:1 ratio into intervention group and control group.
  
        Participants of intervention group will receive bioglass wound dressing in addition with
        clinical optimal treatment plan. Participants of control group will only receive clinical
        optimal treatment plan.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: 2-week reduction rate of wound area
  time frame: 2-week
  measure: 2-week wound healing rate
  time frame: 2-week
  intervention type: Device
  intervention name: Bioactive glass wound dressing
  description: Bioactive glass wound dressing is a dressing covered on the wound bed
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Peking University Third Hospital
  investigator full name: Long Zhang
  investigator title: Professor
  mesh term: Wounds and Injuries
  sharing ipd: No