<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/NCT03248466</url>
  </required_header>
  <id_info>
    <org_study_id>endocrine department of TMMU</org_study_id>
    <nct_id>NCT03248466</nct_id>
  </id_info>
  <brief_title>PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer</brief_title>
  <official_title>Transplantation of Autologous Platelet Rich Gel Combined With Autologous Bone Marrow Mesenchymal Stem Cells for Treatment of Diabetic Foot Ulcer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Military Medical University</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>
      To investigate the treatment effect between Traditional treatment and transplantation of&#xD;
      autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot&#xD;
      ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional&#xD;
      treatment and transplantation of autologous platelet rich gel)，group C (20 diabetic foot&#xD;
      ulcer who give Traditional treatment and transplantation of autologous platelet rich gel&#xD;
      combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood&#xD;
      glucose, glycosylated hemoglobin A1c（HbA1c）, lipid, blood pressure, course of disease, Wound&#xD;
      healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record&#xD;
      respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis&#xD;
      factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline&#xD;
      of all indexes will record, one way Analysis of Variance will be analyzed the significantion&#xD;
      among 3 groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 30, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>diabetic foot ulcer which Wagner classification at 2-3 grade.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amputation rate</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Amputation rate up to 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hospital stay</measure>
    <time_frame>up to 6 months</time_frame>
    <description>hospital stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound healing time</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Wound healing time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transcutaneous oxygen partial pressure</measure>
    <time_frame>Transcutaneous oxygen partial pressure up to 6 months</time_frame>
    <description>Transcutaneous oxygen partial pressure</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>Traditional treatment</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Traditional treatment such as insulin,antidiabetes,dressing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRG combined with BMMSCs transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PRG treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRG combined with BMMSCs transplantation</intervention_name>
    <description>PRG combined with BMMSCs transplantation</description>
    <arm_group_label>PRG combined with BMMSCs transplantation</arm_group_label>
    <arm_group_label>Traditional treatment</arm_group_label>
    <other_name>PRG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetic foot according to The Wagner is 2-3 graded;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes mellitus,presence of autoimmune diabetes;&#xD;
&#xD;
          -  Gestational diabetes;&#xD;
&#xD;
          -  Patients with heart, liver, or renal function impairment;presence of severe infections&#xD;
             or cerebrovascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Southwest Hospital of the Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>+86</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>wu qinan, doctor</last_name>
      <phone>13452867542</phone>
      <email>wqn11@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Endocrine Department, the First Affiliated Hospital of the Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>qinan wu, master</last_name>
      <phone>02368765217</phone>
      <phone_ext>86</phone_ext>
      <email>wqn11@126.com</email>
    </contact>
    <investigator>
      <last_name>qinan wu, master</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Wu Qinan</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>platelet rich gel</keyword>
  <keyword>BMMSCs</keyword>
  <keyword>diabetic foot ulcer</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>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <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/NCT03248466
org study id: endocrine department of TMMU
nct id: NCT03248466
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate the treatment effect between Traditional treatment and transplantation of
      autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.
60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot
      ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional
      treatment and transplantation of autologous platelet rich gel)，group C (20 diabetic foot
      ulcer who give Traditional treatment and transplantation of autologous platelet rich gel
      combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood
      glucose, glycosylated hemoglobin A1c（HbA1c）, lipid, blood pressure, course of disease, Wound
      healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record
      respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis
      factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline
      of all indexes will record, one way Analysis of Variance will be analyzed the significantion
      among 3 groups.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: diabetic foot ulcer which Wagner classification at 2-3 grade.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Amputation rate
time frame: up to 6 months
description: Amputation rate up to 6 months
measure: hospital stay
time frame: up to 6 months
description: hospital stay
measure: Wound healing time
time frame: up to 6 months
description: Wound healing time
measure: Transcutaneous oxygen partial pressure
time frame: Transcutaneous oxygen partial pressure up to 6 months
description: Transcutaneous oxygen partial pressure
arm group label: Traditional treatment
arm group type: Placebo Comparator
description: Traditional treatment such as insulin,antidiabetes,dressing
arm group label: PRG combined with BMMSCs transplantation
arm group type: Experimental
description: Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG combined with BMMSCs
arm group label: PRG treatment
arm group type: No Intervention
description: Traditional treatment such as insulin,antidiabetes,dressing and Autologous PRG
intervention type: Biological
intervention name: PRG combined with BMMSCs transplantation
description: PRG combined with BMMSCs transplantation
arm group label: PRG combined with BMMSCs transplantation
arm group label: Traditional treatment
other name: PRG
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Third Military Medical University
investigator full name: Wu Qinan
investigator title: Doctor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: No