<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/NCT03026855</url>
  </required_header>
  <id_info>
    <org_study_id>TPRX/PRP/NHU/141005</org_study_id>
    <nct_id>NCT03026855</nct_id>
  </id_info>
  <brief_title>Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers</brief_title>
  <official_title>To Demonstrate the Safety and Efficacy of Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TotipotentRX Cell Therapy Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TotipotentRX Cell Therapy Pvt. Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of autologous PRP injection&#xD;
      in combination with topical application of PRP gel in treating chronic or non-healing ulcers&#xD;
      on lower extremity using a rapid, intra-operative, point-of-care technology at the patient's&#xD;
      bedside.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Platelet Rich Plasma (PRP) therapy is an innovative treatment that uses body's own cells to&#xD;
      relieve pain and promote accelerated healing of Non-healing Foot Ulcer /Wound. The body's&#xD;
      response to any tissue injury is to deliver platelets, which play an instrumental role in the&#xD;
      normal healing process by secreting growth factors and attracting stem cells-critical&#xD;
      components of the healing cascade.&#xD;
&#xD;
      Any wound or ulcer on skin that has been present for 4-5 weeks duration, without healing is&#xD;
      called a non-healing ulcer. Non-healing ulcers include venous, arterial, diabetic, pressure&#xD;
      and traumatic ulcers. Cellular therapies using Autologous Platelet Rich Plasma provides new&#xD;
      options for wound healing. The efficacy of the treatment has been proven in surgical&#xD;
      applications, in the treatment of severe burns and in transplantation of cells and tissues.&#xD;
&#xD;
      Local application of a solution of plasma enriched in platelets derived from the patient's&#xD;
      blood intends to trigger the healing process in non-responsive chronic wound, increase the&#xD;
      wound repair rate and reduce pain. PRP is a good option for non-healing wounds because it&#xD;
      utilizes the body's natural healing processes to jump-start wound healing. Plasma which&#xD;
      contains very valuable growth factors is separated from other blood components utilizing a&#xD;
      point of care technology based on density gradient centrifugation. The platelet rich plasma&#xD;
      is harvested and then activated by a mixture of human thrombin and calcium chloride for&#xD;
      initiating the healing cascade followed by PRP injection directly into the ulcer/wound&#xD;
      periphery or spread over a wound in the form of a PRP gel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Wound/ Ulcers Healed</measure>
    <time_frame>24 weeks</time_frame>
    <description>The number of wound/ ulcers healed will be assessed by visual inspection of reduction in wound size at 24 weeks post PRP therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Ulcer Healing</measure>
    <time_frame>24 weeks</time_frame>
    <description>The average time taken for the ulcers to heal post PRP administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in Pain using VAS pain score</measure>
    <time_frame>24 weeks</time_frame>
    <description>Improvement in Pain and discomfort following PRP therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of Life using the SF-36 Questionnaire</measure>
    <time_frame>24 weeks</time_frame>
    <description>Improvement in Quality of Life of the patients following PRP therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related Adverse Events</measure>
    <time_frame>24 weeks</time_frame>
    <description>Safety of the treatment will be assessed by measuring the number of treatment related adverse events and adverse reactions during the follow-up period</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Chronic Ulcer</condition>
  <arm_group>
    <arm_group_label>Autologous PRP Gel and PRP Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autologous PRP will be prepared using an advanced rapid point-of-care technology, the Res-Q™ 60 PRP system at the patient's bed side. The Activator solution for PRP gel will be prepared by combining human thrombin (500 IU/ml) with 1% Calcium Chloride.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Autologous PRP Gel and PRP Injection</intervention_name>
    <description>Autologous PRP prepared using the Res-Q™ 60 PRP system from patient's whole blood, will be injected subcutaneously around the periphery of the wound/ulcer.&#xD;
Based on the wound size and area, autologous platelet gel obtained by spraying simultaneously equal volumes of PRP and activator solution (thrombin with calcium chloride) will be applied topically over the ulcer or wound.&#xD;
Single dose of PRP injections and application of PRP gel will be administered, only on the day of treatment.</description>
    <arm_group_label>Autologous PRP Gel and PRP Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female 18 to 85 years of age&#xD;
&#xD;
          -  Chronic or Non-healing ulcer of any etiology (venous, pressure, arterial or diabetic&#xD;
             foot ulcer) which is at least 4 weeks old&#xD;
&#xD;
          -  Index foot ulcer located on the plantar, medial or lateral aspect of the foot&#xD;
             (including all toe surfaces)&#xD;
&#xD;
          -  Wound area (length x width) measurement must be between 0.5 cm^2 and 10 cm^2,&#xD;
             inclusive&#xD;
&#xD;
          -  If more than one non-healing ulcers is present, the largest wound will be selected&#xD;
&#xD;
          -  Index ulcer must be clinically non-infected&#xD;
&#xD;
          -  Full-thickness ulcer without exposure of bone, muscle, ligament or tendon&#xD;
&#xD;
          -  Written informed consent must be obtained from either the patient or the patients&#xD;
             legally acceptable representative prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known sensitivity to components of the PRP kit (calcium chloride,&#xD;
             thrombin, acid citrate dextrose solution A (ACD-A))&#xD;
&#xD;
          -  Smokers and individuals with systemic disease or history of anticoagulant,&#xD;
             immuno-suppressive or antibiotic therapy in the last 3 months&#xD;
&#xD;
          -  Platelet count &lt; 105 x 10^3/ uL (according to CBC)&#xD;
&#xD;
          -  Hemoglobin level &lt; 10 g/dL (according to CBC)&#xD;
&#xD;
          -  Wound is clinically infected&#xD;
&#xD;
          -  Presence of platelet dysfunction syndrome or critical thrombocytopenia&#xD;
&#xD;
          -  Bleeding disorders, collagen vascular disease or severe cardiovascular disorder&#xD;
&#xD;
          -  Any malignancy other than non-melanoma skin cancer&#xD;
&#xD;
          -  Patient is currently receiving or has received radiation or chemotherapy within 3&#xD;
             months prior to treatment&#xD;
&#xD;
          -  If female, patient is pregnant, nursing or plans to become pregnant during the&#xD;
             duration of the study&#xD;
&#xD;
          -  Subject has inadequate venous access for blood draw required for PRP preparation&#xD;
&#xD;
          -  Any chronic condition requiring the use of systemic corticosteroids 30 days prior to&#xD;
             study entry and anytime during the course of the study&#xD;
&#xD;
          -  Subject is on dialysis or has uncontrolled sugar levels&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Suhail N Bukhari, MBBS, DNB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fortis Escorts Heart Institute and Research Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fortis Escorts Heart Institute and Research Centre</name>
      <address>
        <city>Delhi</city>
        <zip>110025</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autologous PRP</keyword>
  <keyword>Non-healing ulcer</keyword>
  <keyword>Point-of-care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03026855
org study id: TPRX/PRP/NHU/141005
nct id: NCT03026855
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of autologous PRP injection
      in combination with topical application of PRP gel in treating chronic or non-healing ulcers
      on lower extremity using a rapid, intra-operative, point-of-care technology at the patient's
      bedside.
Platelet Rich Plasma (PRP) therapy is an innovative treatment that uses body's own cells to
      relieve pain and promote accelerated healing of Non-healing Foot Ulcer /Wound. The body's
      response to any tissue injury is to deliver platelets, which play an instrumental role in the
      normal healing process by secreting growth factors and attracting stem cells-critical
      components of the healing cascade.

      Any wound or ulcer on skin that has been present for 4-5 weeks duration, without healing is
      called a non-healing ulcer. Non-healing ulcers include venous, arterial, diabetic, pressure
      and traumatic ulcers. Cellular therapies using Autologous Platelet Rich Plasma provides new
      options for wound healing. The efficacy of the treatment has been proven in surgical
      applications, in the treatment of severe burns and in transplantation of cells and tissues.

      Local application of a solution of plasma enriched in platelets derived from the patient's
      blood intends to trigger the healing process in non-responsive chronic wound, increase the
      wound repair rate and reduce pain. PRP is a good option for non-healing wounds because it
      utilizes the body's natural healing processes to jump-start wound healing. Plasma which
      contains very valuable growth factors is separated from other blood components utilizing a
      point of care technology based on density gradient centrifugation. The platelet rich plasma
      is harvested and then activated by a mixture of human thrombin and calcium chloride for
      initiating the healing cascade followed by PRP injection directly into the ulcer/wound
      periphery or spread over a wound in the form of a PRP gel.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Wound/ Ulcers Healed
time frame: 24 weeks
description: The number of wound/ ulcers healed will be assessed by visual inspection of reduction in wound size at 24 weeks post PRP therapy
measure: Time to Ulcer Healing
time frame: 24 weeks
description: The average time taken for the ulcers to heal post PRP administration
measure: Reduction in Pain using VAS pain score
time frame: 24 weeks
description: Improvement in Pain and discomfort following PRP therapy
measure: Changes in Quality of Life using the SF-36 Questionnaire
time frame: 24 weeks
description: Improvement in Quality of Life of the patients following PRP therapy
measure: Number of participants with treatment-related Adverse Events
time frame: 24 weeks
description: Safety of the treatment will be assessed by measuring the number of treatment related adverse events and adverse reactions during the follow-up period
arm group label: Autologous PRP Gel and PRP Injection
arm group type: Experimental
description: Autologous PRP will be prepared using an advanced rapid point-of-care technology, the Res-Q™ 60 PRP system at the patient's bed side. The Activator solution for PRP gel will be prepared by combining human thrombin (500 IU/ml) with 1% Calcium Chloride.
intervention type: Biological
intervention name: Autologous PRP Gel and PRP Injection
description: Autologous PRP prepared using the Res-Q™ 60 PRP system from patient's whole blood, will be injected subcutaneously around the periphery of the wound/ulcer.
Based on the wound size and area, autologous platelet gel obtained by spraying simultaneously equal volumes of PRP and activator solution (thrombin with calcium chloride) will be applied topically over the ulcer or wound.
Single dose of PRP injections and application of PRP gel will be administered, only on the day of treatment.
arm group label: Autologous PRP Gel and PRP Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Dr. Suhail N Bukhari, MBBS, DNB
role: Principal Investigator
affiliation: Fortis Escorts Heart Institute and Research Centre
facility: 
country: India
responsible party type: Sponsor
mesh term: Ulcer
sharing ipd: No