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/NCT05979584</url>
    </required_header>
    <id_info>
      <org_study_id>Long2023-DFU-PFP</org_study_id>
      <nct_id>NCT05979584</nct_id>
    </id_info>
    <brief_title>Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Foot Ulcer：a Randomized Controlled Trial</brief_title>
    <official_title>Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Foot Ulcer：a Randomized Controlled 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 compare the efficacy and safety of Platelet&#xD;
        Rich Plasma VS Platelet Fibrin Plasma in patients with diabetes foot ulcer. The main question&#xD;
        it aims to answer are:&#xD;
  &#xD;
          -  Whether the Platelet Fibrin Plasma have noninferior efficacy than Platelet Rich Plasma&#xD;
             in treatment of diabetes foot ulcer？&#xD;
  &#xD;
          -  Whether the Platelet Fibrin Plasma have noninferior safety than Platelet Rich Plasma in&#xD;
             treatment of diabetes foot ulcer？ Participants will be assigned with a 1:1 ratio into&#xD;
             intervention group and control group.&#xD;
  &#xD;
        Participants of intervention group will receive Platelet Fibrin Plasma in addition with&#xD;
        clinical optimal treatment plan after the wound bed preparation for closure. Participants of&#xD;
        intervention group will receive Platelet Rich Plasma in addition with clinical optimal&#xD;
        treatment plan after the wound bed preparation for closure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 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>4-week wound healing rate</measure>
      <time_frame>4-week</time_frame>
      <description>By D28, the proportion of healed wounds in the total number of cases</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Diabetic Foot</condition>
    <arm_group>
      <arm_group_label>Platelet Fibrin Plasma</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Platelet Rich Plasma</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Platelet Fibrin Plasma</intervention_name>
      <description>Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.</description>
      <arm_group_label>Platelet Fibrin Plasma</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Platelet Rich Plasma</intervention_name>
      <description>Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.</description>
      <arm_group_label>Platelet Rich Plasma</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The patient is aged 18-80 years old;&#xD;
  &#xD;
            2. Diagnosed as type 1 or type 2 diabetes according to the World Health Organization&#xD;
               standard, blood sugar has been controlled before enrollment, and the level of Glycated&#xD;
               hemoglobin HbA1c is less than 10%;&#xD;
  &#xD;
            3. diabetes wounds with poor healing or prolonged healing need standard wound treatment;&#xD;
  &#xD;
            4. There is no disseminated infection or the disseminated infection has been controlled;&#xD;
  &#xD;
            5. After preparing the wound bed, the condition for using platelet plasma to close the&#xD;
               wound is met;&#xD;
  &#xD;
            6. Voluntarily 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. Severe ischemia of the wound surface, unable to seek medical attention or not yet&#xD;
               corrected;&#xD;
  &#xD;
            3. Uncontrolled systemic or disseminated infections;&#xD;
  &#xD;
            4. Blood glucose is out of control or not yet effectively controlled;&#xD;
  &#xD;
            5. Blood system diseases with uncorrected coagulation dysfunction or platelet&#xD;
               dysfunction;&#xD;
  &#xD;
            6. There is active bleeding inside the wound, and routine basic treatment plans cannot be&#xD;
               implemented;&#xD;
  &#xD;
            7. Platelets ≤ 80 × 10^9, hemoglobin&lt;90g/L;&#xD;
  &#xD;
            8. Patients with advanced malignant tumors;&#xD;
  &#xD;
            9. Active period of autoimmune diseases;&#xD;
  &#xD;
           10. The patient is unable to cooperate or has mental disorders;&#xD;
  &#xD;
           11. According to the judgment of the researchers, the patient has a clear and irremovable&#xD;
               cause that affects wound healing, which is not suitable for this study or cannot&#xD;
               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 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 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>
    <keyword>Platelet Rich Plasma</keyword>
    <keyword>Platelet Fibrin Plasma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetic Foot</mesh_term>
      <mesh_term>Foot 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/NCT05979584
  org study id: Long2023-DFU-PFP
  nct id: NCT05979584
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized control trial is to compare the efficacy and safety of Platelet
        Rich Plasma VS Platelet Fibrin Plasma in patients with diabetes foot ulcer. The main question
        it aims to answer are:
  
          -  Whether the Platelet Fibrin Plasma have noninferior efficacy than Platelet Rich Plasma
             in treatment of diabetes foot ulcer？
  
          -  Whether the Platelet Fibrin Plasma have noninferior safety than Platelet Rich Plasma in
             treatment of diabetes foot ulcer？ Participants will be assigned with a 1:1 ratio into
             intervention group and control group.
  
        Participants of intervention group will receive Platelet Fibrin Plasma in addition with
        clinical optimal treatment plan after the wound bed preparation for closure. Participants of
        intervention group will receive Platelet Rich Plasma in addition with clinical optimal
        treatment plan after the wound bed preparation for closure.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: 4-week wound healing rate
  time frame: 4-week
  description: By D28, the proportion of healed wounds in the total number of cases
  arm group label: Platelet Fibrin Plasma
  arm group type: Experimental
  description: Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
  arm group label: Platelet Rich Plasma
  arm group type: Placebo Comparator
  description: Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
  intervention type: Device
  intervention name: Platelet Fibrin Plasma
  description: Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
  arm group label: Platelet Fibrin Plasma
  intervention type: Device
  intervention name: Platelet Rich Plasma
  description: Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
  arm group label: Platelet Rich Plasma
  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: Diabetic Foot
  mesh term: Foot Ulcer