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/NCT05975827</url>
    </required_header>
    <id_info>
      <org_study_id>Long2023-DFU-Sterile dressing</org_study_id>
      <nct_id>NCT05975827</nct_id>
    </id_info>
    <brief_title>Sterile Wound Care Liquid Dressing in Treatment of Diabetes Foot Ulcer: a Randomized Control Trial</brief_title>
    <official_title>Sterile Wound Care Liquid Dressing in Treatment of Diabetes Foot Ulcer: a Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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 the sterile&#xD;
        wound care liquid dressing in patients with diabetes foot ulcer in different stages. The main&#xD;
        question it aims to answer are:&#xD;
  &#xD;
          -  Whether the sterile wound care liquid dressing have better efficacy and safety than&#xD;
             blank control in treatment of diabetes foot ulcer in infection progressive stage？&#xD;
  &#xD;
          -  Whether the sterile wound care liquid dressing have better efficacy and safety than&#xD;
             blank control in treatment of diabetes foot ulcer in necrosis stable stage？&#xD;
  &#xD;
          -  Whether the sterile wound care liquid dressing have better efficacy and safety than&#xD;
             blank control in treatment of chronic wound in granulation growth stage？ Participants&#xD;
             will be assigned with a 1:1 ratio into intervention group and control group.&#xD;
  &#xD;
        Participants of intervention group will receive sterile wound care liquid dressing in&#xD;
        addition with clinical optimal treatment plan. Participants of control group will only&#xD;
        receive clinical 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">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Single Group 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>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Diabetes</condition>
    <condition>Foot Ulcer</condition>
    <arm_group>
      <arm_group_label>Sterile Wound Care Liquid Dressing</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sterile Wound Care Liquid Dressing</intervention_name>
      <description>Sterile wound care liquid dressing is used in the wound treatment</description>
      <arm_group_label>Sterile Wound Care Liquid Dressing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The patient is aged 18-80 years old;&#xD;
  &#xD;
            2. Diagnose diabetes according to WHO standards;&#xD;
  &#xD;
            3. Diagnose diabetes ulcer;&#xD;
  &#xD;
            4. Confirmed as one of the stages of infection progression, necrosis stable, or&#xD;
               granulation growth;&#xD;
  &#xD;
            5. The Pregnancy test of female patients with Fertility must be negative;&#xD;
  &#xD;
            6. Non eye damage to the wound surface and natural cavities such as the ear cavity, nasal&#xD;
               cavity, and abdominal cavity;&#xD;
  &#xD;
            7. 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;
               respiratory failure, kidney failure, etc. 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;,4. Serum albumin &lt; 20g/L; Hemoglobin &lt; 60g/L; Platelets&lt;50 × 10^9/L;&#xD;
  &#xD;
          5. Patients with advanced malignant tumors; 6. Active period of autoimmune diseases; 7.&#xD;
          Allergic history of sterile wound care liquid dressings; 8. The patient is unable to&#xD;
          cooperate or has mental disorders; 9. Pregnant and lactating women;,10. Eye damage and&#xD;
          natural cavities such as the ear, nose, and abdominal cavity; 11. Skin tumors; 12. Active&#xD;
          skin diseases; 13. According to the judgment of the researchers, the patient has a clear&#xD;
          and irremovable cause that 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>
    <overall_contact>
      <last_name>Long Zhang, MD</last_name>
      <phone>+86 010-82266699</phone>
      <email>longzh2000@163.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 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>Diabetes foot ulcer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Foot Ulcer</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Ulcer</mesh_term>
    </condition_browse>
    <!-- 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/NCT05975827
  org study id: Long2023-DFU-Sterile dressing
  nct id: NCT05975827
  lead sponsor: 
  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 the sterile
        wound care liquid dressing in patients with diabetes foot ulcer in different stages. The main
        question it aims to answer are:
  
          -  Whether the sterile wound care liquid dressing have better efficacy and safety than
             blank control in treatment of diabetes foot ulcer in infection progressive stage？
  
          -  Whether the sterile wound care liquid dressing have better efficacy and safety than
             blank control in treatment of diabetes foot ulcer in necrosis stable stage？
  
          -  Whether the sterile wound care liquid 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 sterile wound care liquid dressing in
        addition with clinical optimal treatment plan. Participants of control group will only
        receive clinical optimal treatment plan.
  allocation: Randomized
  intervention model: Single Group 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
  arm group label: Sterile Wound Care Liquid Dressing
  arm group type: Experimental
  arm group label: Control
  arm group type: No Intervention
  intervention type: Device
  intervention name: Sterile Wound Care Liquid Dressing
  description: Sterile wound care liquid dressing is used in the wound treatment
  arm group label: Sterile Wound Care Liquid Dressing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Long Zhang, MD
  phone: +86 010-82266699
  email: longzh2000@163.com
  responsible party type: Principal Investigator
  investigator affiliation: Peking University Third Hospital
  investigator full name: Long Zhang
  investigator title: Professor
  mesh term: Foot Ulcer
  mesh term: Diabetes Mellitus
  mesh term: Ulcer