<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/NCT02972528</url>
  </required_header>
  <id_info>
    <org_study_id>DFUUJCTC</org_study_id>
    <nct_id>NCT02972528</nct_id>
  </id_info>
  <brief_title>The Use of Allogenic Platelet Rich Plasma for the Treatment of Diabetic Foot Ulcer</brief_title>
  <official_title>Allogeneic Defibrinated Platelet Rich Plasma Lysate for the Healing of Chronic Diabetic Foot Ulcer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanan Jafar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jordan</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>
      Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed&#xD;
      with Diabetic Foot Ulcer (DFU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, allogenic, defibrinated platelet rich plasma lysate will be used as a direct&#xD;
      injection into the periphery of diabetic chronic foot ulcers which have not healed using&#xD;
      standard of care. Investigators anticipate a significant response in treated individuals&#xD;
      measured by the percentage of skin restoration achieved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 3, 2018</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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 Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the efficacy of allogenic Platelet Lysate injection by clinical examination</measure>
    <time_frame>4 months</time_frame>
    <description>To determine short term speed and effectiveness of allogeneic, platelet rich plasma lysate on the healing of diabetic foot ulceration compared with Platelet Poor Plasma by measuring the diameter of ulcers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>Platelet Lysate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 5ml peri-lesional injections of Platelet Lysate at weekly intervals, for 4 consecutive times (week 0,1,2,3).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Platelet Poor Plasma</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive 5ml peri-lesional injections of Platelet Poor Plasma at weekly intervals, for 4 consecutive times (week 0,1,2,3).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet Lysate</intervention_name>
    <description>Direct injection of allogenic Platelet Lysate</description>
    <arm_group_label>Platelet Lysate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet Poor Plasma</intervention_name>
    <description>Direct injection of allogenic Platelet Poor Plasma</description>
    <arm_group_label>Platelet Poor Plasma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Persons with type 1 or type 2 diabetes between the ages of 18 and 70 with an ulcer of&#xD;
             at least 4 weeks duration&#xD;
&#xD;
          2. HemoglobinA1C (HbA1c) &lt; 12&#xD;
&#xD;
          3. Index foot ulcer located on the plantar, medial, or lateral aspect of the foot&#xD;
             (including all toe surfaces); and wound area (length x width) measurement between 2&#xD;
             cm2 and 20 cm2, inclusive.&#xD;
&#xD;
          4. Wounds located under a Charcot deformity had to be free of acute changes and must have&#xD;
             under gone appropriate structural consolidation.&#xD;
&#xD;
          5. The index ulcer had to be clinically non-infected and full - thickness without&#xD;
             exposure of bone, ligaments, or tendons.&#xD;
&#xD;
          6. The protocol requires that post debridement the ulcer would be free of necrotic&#xD;
             debris, foreign bodies or sinus tracts.&#xD;
&#xD;
          7. Non- invasive vascular testing ankle brachial index (ABI).&#xD;
&#xD;
          8. Physical examination (including a Semmes-Weinstein monofilament test for neuropathy)&#xD;
&#xD;
          9. Blood tests to be obtained Complete Blood Count and HbA1c.&#xD;
&#xD;
         10. Approved, informed, signed consent.&#xD;
&#xD;
         11. Negative test for Hepatitis C (HC), Hepatitis B (HB), Human Immunodeficiency Virus 1&#xD;
             and 2 (HIVI and II), Venereal Disease Research Laboratory (VDRL).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient currently enrolled in another investigational device or drug trial or&#xD;
             previously enrolled (within last 30 days) in investigative research of a device or&#xD;
             pharmaceutical agent.&#xD;
&#xD;
          2. Ulcer decreased ≥50% in area during 7-day screening period.&#xD;
&#xD;
          3. Ulcer is due to non-diabetic etiology.&#xD;
&#xD;
          4. Patient's blood vessels are non-compressible for ABI testing.&#xD;
&#xD;
          5. Evidence of gangrene in ulcer or on any part of the foot.&#xD;
&#xD;
          6. Patient has radiographic evidence consistent with diagnosis of acute Charcot foot.&#xD;
&#xD;
          7. Patient is currently receiving or has received radiation or chemotherapy within 3&#xD;
             months of randomization.&#xD;
&#xD;
          8. Patient has received growth factor therapy within 7 days of randomization.&#xD;
&#xD;
          9. Screening hemoglobin &lt;10.5 mg/dL.&#xD;
&#xD;
         10. Screening platelet count &lt; 100 x 109/L.&#xD;
&#xD;
         11. Patient is undergoing renal dialysis, has known immune insufficiency, known abnormal&#xD;
             platelet activation disorders - ie, gray platelet syndrome, liver disease, active&#xD;
             cancer (except remote basal cell of the skin), eating/ nutritional,hematologic,&#xD;
             collagen vascular disease, rheumatic disease, or bleeding disorders.&#xD;
&#xD;
         12. History of peripheral vascular repair within the 30 days of randomization&#xD;
&#xD;
         13. Patient has known or suspected osteomyelitis.&#xD;
&#xD;
         14. Surgical correction (other than debridement) required for ulcer to heal.&#xD;
&#xD;
         15. Index ulcer has exposed tendons, ligaments, muscle, or bone.&#xD;
&#xD;
         16. Patient is known to have a psychological, developmental, physical, emotional, or&#xD;
             social disorder, or any other situation that may interfere with compliance with study&#xD;
             requirements and/or healing of the ulcer&#xD;
&#xD;
         17. History of alcohol or drug abuse within the last year prior to randomization.&#xD;
&#xD;
         18. Patient has inadequate venous access for blood draw.&#xD;
&#xD;
         19. Positive test for HC, HB, HIVI and II, VDRL.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abdallah Awidi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cell Therapy Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hanan Jafar, PhD</last_name>
    <phone>00962798871087</phone>
    <email>hanan.jafar@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cell Therapy Center</name>
      <address>
        <city>Amman</city>
        <zip>11942</zip>
        <country>Jordan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abdalla Awidi, MD</last_name>
      <phone>0096265355000</phone>
      <phone_ext>23960</phone_ext>
      <email>abdalla.awidi@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>August 25, 2019</last_update_submitted>
  <last_update_submitted_qc>August 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Jordan</investigator_affiliation>
    <investigator_full_name>Hanan Jafar</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>DFU</keyword>
  <keyword>Diabetic Foot Ulcer</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Platelet Rich 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>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02972528
org study id: DFUUJCTC
nct id: NCT02972528
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Allogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed
      with Diabetic Foot Ulcer (DFU).
In this study, allogenic, defibrinated platelet rich plasma lysate will be used as a direct
      injection into the periphery of diabetic chronic foot ulcers which have not healed using
      standard of care. Investigators anticipate a significant response in treated individuals
      measured by the percentage of skin restoration achieved.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the injection
time frame: 3 months
description: Evaluate the safety of this treatment, by gathering and assessing the number, timing, severity, duration, and resolution of related adverse events.
measure: Assess the efficacy of allogenic Platelet Lysate injection by clinical examination
time frame: 4 months
description: To determine short term speed and effectiveness of allogeneic, platelet rich plasma lysate on the healing of diabetic foot ulceration compared with Platelet Poor Plasma by measuring the diameter of ulcers.
arm group label: Platelet Lysate
arm group type: Active Comparator
description: Patients will receive 5ml peri-lesional injections of Platelet Lysate at weekly intervals, for 4 consecutive times (week 0,1,2,3).
arm group label: Platelet Poor Plasma
arm group type: Placebo Comparator
description: Patients will receive 5ml peri-lesional injections of Platelet Poor Plasma at weekly intervals, for 4 consecutive times (week 0,1,2,3).
intervention type: Biological
intervention name: Platelet Lysate
description: Direct injection of allogenic Platelet Lysate
arm group label: Platelet Lysate
intervention type: Biological
intervention name: Platelet Poor Plasma
description: Direct injection of allogenic Platelet Poor Plasma
arm group label: Platelet Poor Plasma
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Abdallah Awidi, MD
role: Study Director
affiliation: Cell Therapy Center
last name: Hanan Jafar, PhD
phone: 00962798871087
email: hanan.jafar@gmail.com
facility: 
status: Recruiting
contact: 
country: Jordan
responsible party type: Sponsor-Investigator
investigator affiliation: University of Jordan
investigator full name: Hanan Jafar
investigator title: Researcher
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: Undecided