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/NCT06014437</url>
    </required_header>
    <id_info>
      <org_study_id>Jinshan hospital</org_study_id>
      <nct_id>NCT06014437</nct_id>
    </id_info>
    <brief_title>Study on Regeneration of Skin Defects in Diabetic Ulcers Treated With New Electrospun Material PLCL/Fg</brief_title>
    <official_title>Study on Regeneration of Skin Defects in Diabetic Ulcers Treated With New Electrospun Material Poly (L-lactide-co-caprolactone) and Formulated Porcine Fibrinogen</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guili Wang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Prospective cohort studies through clinical trials. Obtained a large amount of real-world&#xD;
        data to explore the efficacy of PLCL/Fg dressings for specific clinical applications.&#xD;
  &#xD;
        Published 1 relevant SCIE paper. Provide a large amount of data support for the application&#xD;
        of PLCL/Fg dressing in diabetic foot ulcer wound repair through basic experimental and&#xD;
        clinical experimental studies. It can provide a practical and effective biomaterial for the&#xD;
        treatment of clinical skin wound structure and function reconstruction, make the patient's&#xD;
        wound healing as soon as possible, benefit the general public, reduce medical expenditure,&#xD;
        reduce the burden on the society, lay the foundation for the industrialization and&#xD;
        marketization of national innovative medical devices, and help to improve the international&#xD;
        status and value of the application.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
    <phase>Phase 4</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>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of complete wound closure during treatment and follow-up (12 weeks). (Outpatient follow-up 2-3 times per week, standardized photographs and measurement of wound size)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Complete healing is defined as complete re-epithelialization of the ulcer bed with no discharge. Speed of healing is calculated by measuring the size or percentage reduction in wound area per week.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Diabetic Foot</condition>
    <arm_group>
      <arm_group_label>PLCL/Fg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Routine ulcerated wounds were cleaned, and the test group was given an equal-sized PLCL/Fg dressing to cover the wounds.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Routine ulcerated wounds were cleaned and changed, and the control group was given an alginate dressing of equal size to cover the wounds.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PLCL/Fg group</intervention_name>
      <description>Routine ulcerated wounds were cleaned, and the test group was given an equal-sized PLCL/Fg dressing to cover the wounds.</description>
      <arm_group_label>PLCL/Fg</arm_group_label>
      <other_name>PLCL/Fg dressing</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>control group</intervention_name>
      <description>Routine ulcerated wounds were cleaned and changed, and the control group was given an alginate dressing of equal size to cover the wounds</description>
      <arm_group_label>control group</arm_group_label>
      <other_name>alginate dressing</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 18 and 90 years; type 1 or type 2 diabetes mellitus; history of ulceration&#xD;
               for more than 4 weeks at enrollment; wound area between 1 and 25 square centimeters;&#xD;
               wound depth of Wagner grades 1 and 2; and an ABI of 0.7 to 1.3 on the affected lower&#xD;
               extremity or a transcutaneous oxygen pressure of greater than or equal to 30 mmHg.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Wound healing percentage greater than 30% during wound preparation (7 days); any&#xD;
               infection, osteomyelitis, or other condition that may affect wound healing, such as&#xD;
               deep vein thrombosis, rheumatoid arthritis, systemic lupus erythematosus, or any other&#xD;
               systemic inflammatory disease.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>zhihui dong</last_name>
      <role>Study Chair</role>
      <affiliation>Department of Vascular Surgery, Jinshan Hospital, Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>guili wang</last_name>
      <phone>+8618264188121</phone>
      <email>wgl4611@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Vascular Surgery, Jinshan Hospital, Fudan University</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>guili wang</last_name>
        <phone>+8618264188121</phone>
        <email>wgl4611@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Guili Wang</investigator_full_name>
      <investigator_title>Jinshan hospital Fudan University. Guili Wang is Principal Investigator of vascular surgery</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetic Foot</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will be made available on request.</ipd_description>
    </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/NCT06014437
  org study id: Jinshan hospital
  nct id: NCT06014437
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Prospective cohort studies through clinical trials. Obtained a large amount of real-world
        data to explore the efficacy of PLCL/Fg dressings for specific clinical applications.
  
        Published 1 relevant SCIE paper. Provide a large amount of data support for the application
        of PLCL/Fg dressing in diabetic foot ulcer wound repair through basic experimental and
        clinical experimental studies. It can provide a practical and effective biomaterial for the
        treatment of clinical skin wound structure and function reconstruction, make the patient's
        wound healing as soon as possible, benefit the general public, reduce medical expenditure,
        reduce the burden on the society, lay the foundation for the industrialization and
        marketization of national innovative medical devices, and help to improve the international
        status and value of the application.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: Incidence of complete wound closure during treatment and follow-up (12 weeks). (Outpatient follow-up 2-3 times per week, standardized photographs and measurement of wound size)
  time frame: 12 weeks
  description: Complete healing is defined as complete re-epithelialization of the ulcer bed with no discharge. Speed of healing is calculated by measuring the size or percentage reduction in wound area per week.
  arm group label: PLCL/Fg
  arm group type: Experimental
  description: Routine ulcerated wounds were cleaned, and the test group was given an equal-sized PLCL/Fg dressing to cover the wounds.
  arm group label: control group
  arm group type: Active Comparator
  description: Routine ulcerated wounds were cleaned and changed, and the control group was given an alginate dressing of equal size to cover the wounds.
  intervention type: Drug
  intervention name: PLCL/Fg group
  description: Routine ulcerated wounds were cleaned, and the test group was given an equal-sized PLCL/Fg dressing to cover the wounds.
  arm group label: PLCL/Fg
  other name: PLCL/Fg dressing
  intervention type: Drug
  intervention name: control group
  description: Routine ulcerated wounds were cleaned and changed, and the control group was given an alginate dressing of equal size to cover the wounds
  arm group label: control group
  other name: alginate dressing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: zhihui dong
  role: Study Chair
  affiliation: Department of Vascular Surgery, Jinshan Hospital, Fudan University
  last name: guili wang
  phone: +8618264188121
  email: wgl4611@126.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Fudan University
  investigator full name: Guili Wang
  investigator title: Jinshan hospital Fudan University. Guili Wang is Principal Investigator of vascular surgery
  mesh term: Diabetic Foot
  sharing ipd: No
  ipd description: Data will be made available on request.