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/NCT05974982</url>
    </required_header>
    <id_info>
      <org_study_id>NO.F.2-81/2022-GENL/249/JPMC</org_study_id>
      <nct_id>NCT05974982</nct_id>
    </id_info>
    <brief_title>Treatment Outcome of Autologous PRP Versus Conventional Therapy Among Patients With Chronic Venous Leg Ulcers</brief_title>
    <official_title>Comparison of the Outcome of Treatment With Autologous Platelet Rich Plasma Versus Conventional Therapy for Patients Presenting With Chronic Venous Leg Ulcers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jinnah Postgraduate Medical Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jinnah Postgraduate Medical Centre</source>
    <oversight_info>
      <has_dmc>No</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 use of PRP has dramatically increased in the fields of orthopedics, spine surgery,&#xD;
        reconstructive plastic surgery, oral and maxillofacial surgery, and dermatological&#xD;
        indications. Nonetheless, its use in the treatment of wounds is not as widespread as in other&#xD;
        fields. In this experimental study, the treatment outcome of autologous PRP was assessed in&#xD;
        comparison to conventional therapy among patients with chronic venous leg ulcers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Venous ulcers are the most common form of leg ulcers which have a significant impact on&#xD;
        quality of life and work productivity. In addition, the costs associated with the long-term&#xD;
        care of these chronic wounds are substantial. Conventional therapies such as dressings,&#xD;
        surgical debridement, compression bandage, and even skin grafting cannot provide satisfactory&#xD;
        healing since these treatments are not able to provide necessary growth factors that can&#xD;
        modulate healing processes. Autologous platelet-rich plasma (PRP) is a safe, simple,&#xD;
        affordable, and less expensive procedure in the treatment of chronic ulcers with reportedly&#xD;
        good results. Since it is an autologous method, it is biocompatible and safe. Data from this&#xD;
        would help in establishing it as a treatment of choice, thereby leading to a reduction in&#xD;
        cost and benefiting the patient both financially and psychologically.&#xD;
  &#xD;
        PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e.,&#xD;
        five times more than normal platelet counts. PRP enhances wound healing by promoting the&#xD;
        healing process by seven growth factors present in it. They are platelet-derived growth&#xD;
        factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal&#xD;
        growth factor, and transforming growth factor. These growth factors are important in&#xD;
        modulating mesenchymal cell recruitment, proliferation, and extra-cellular matrix synthesis&#xD;
        during the healing process.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Actual">May 25, 2023</completion_date>
    <primary_completion_date type="Actual">May 25, 2023</primary_completion_date>
    <phase>Phase 1</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Complete healing</measure>
      <time_frame>9 months</time_frame>
      <description>Complete healing is defined as 100% epithelialization</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Length of ulcer</measure>
      <time_frame>9 months</time_frame>
      <description>Length of ulcer in cm at the end of treatment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Width of ulcer</measure>
      <time_frame>9 months</time_frame>
      <description>Width of ulcer in cm at the end of treatment</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">48</enrollment>
    <condition>Venous Leg Ulcer</condition>
    <arm_group>
      <arm_group_label>Platelet-rich plasma</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Under aseptic precautions 20 ml of venous blood was drawn and added to a test tube containing acid citrate dextrose in a ratio of 9:1 (blood: Acid citrate dextrose), centrifuged at 5000 rpm for 15 min to separate the red blood cells from the platelets and plasma. Then the supernatant and the buffy coat composed of platelets and plasma were collected and centrifuged again at 2000 rpm for 5-10 min. The bottom layer about 1.5 ml was taken and 10% calcium chloride was added (0.3 ml for 1 ml of PRP). Then the activated PRP was applied to the wound after proper surgical debridement and was dressed with a non-absorbent dressing (paraffin gauze). This process was repeated once weekly for 6 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>These patients were treated conservatively by compression using graduated elastic stockings below the knee and dressing using saline and vaseline gauze weekly for 6 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>PRP</intervention_name>
      <description>PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e., five times more than normal platelet counts. PRP enhances wound healing by promoting the healing process by seven growth factors present in it. They are platelet derived growth factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, transforming growth factor.</description>
      <arm_group_label>Platelet-rich plasma</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional therapy</intervention_name>
      <description>Conventional therapy</description>
      <arm_group_label>Conventional therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 30-80 years of any gender presented with chronic venous leg ulcers&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with history of peripheral arterial disease.&#xD;
  &#xD;
            -  Patients with history of acute venous thromboembolism.&#xD;
  &#xD;
            -  Patients with platelet count less than 150000.&#xD;
  &#xD;
            -  Patients with history of bleeding disorders.&#xD;
  &#xD;
            -  Patients with history of osteoporosis.&#xD;
  &#xD;
            -  Patients with history of peripheral neuropathy.&#xD;
  &#xD;
            -  Pregnant patients assessed by history and confirmed by dating scan.&#xD;
  &#xD;
            -  Patients with history of congestive cardiac failure, chronic liver disease, asthma,&#xD;
               COPD, or stroke.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rabia Ghafoor</last_name>
      <role>Study Director</role>
      <affiliation>Jinnah Post Graduate Medical Centre</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Jinnah Post graduate Medical centre</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <zip>75510</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Jinnah Postgraduate Medical Centre</investigator_affiliation>
      <investigator_full_name>Faiza Inam Siddiqui</investigator_full_name>
      <investigator_title>Resident dermatologist (fcps)</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Varicose Ulcer</mesh_term>
      <mesh_term>Leg Ulcer</mesh_term>
      <mesh_term>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/NCT05974982
  org study id: NO.F.2-81/2022-GENL/249/JPMC
  nct id: NCT05974982
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The use of PRP has dramatically increased in the fields of orthopedics, spine surgery,
        reconstructive plastic surgery, oral and maxillofacial surgery, and dermatological
        indications. Nonetheless, its use in the treatment of wounds is not as widespread as in other
        fields. In this experimental study, the treatment outcome of autologous PRP was assessed in
        comparison to conventional therapy among patients with chronic venous leg ulcers.
  Venous ulcers are the most common form of leg ulcers which have a significant impact on
        quality of life and work productivity. In addition, the costs associated with the long-term
        care of these chronic wounds are substantial. Conventional therapies such as dressings,
        surgical debridement, compression bandage, and even skin grafting cannot provide satisfactory
        healing since these treatments are not able to provide necessary growth factors that can
        modulate healing processes. Autologous platelet-rich plasma (PRP) is a safe, simple,
        affordable, and less expensive procedure in the treatment of chronic ulcers with reportedly
        good results. Since it is an autologous method, it is biocompatible and safe. Data from this
        would help in establishing it as a treatment of choice, thereby leading to a reduction in
        cost and benefiting the patient both financially and psychologically.
  
        PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e.,
        five times more than normal platelet counts. PRP enhances wound healing by promoting the
        healing process by seven growth factors present in it. They are platelet-derived growth
        factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal
        growth factor, and transforming growth factor. These growth factors are important in
        modulating mesenchymal cell recruitment, proliferation, and extra-cellular matrix synthesis
        during the healing process.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Complete healing
  time frame: 9 months
  description: Complete healing is defined as 100% epithelialization
  measure: Length of ulcer
  time frame: 9 months
  description: Length of ulcer in cm at the end of treatment
  measure: Width of ulcer
  time frame: 9 months
  description: Width of ulcer in cm at the end of treatment
  arm group label: Platelet-rich plasma
  arm group type: Experimental
  description: Under aseptic precautions 20 ml of venous blood was drawn and added to a test tube containing acid citrate dextrose in a ratio of 9:1 (blood: Acid citrate dextrose), centrifuged at 5000 rpm for 15 min to separate the red blood cells from the platelets and plasma. Then the supernatant and the buffy coat composed of platelets and plasma were collected and centrifuged again at 2000 rpm for 5-10 min. The bottom layer about 1.5 ml was taken and 10% calcium chloride was added (0.3 ml for 1 ml of PRP). Then the activated PRP was applied to the wound after proper surgical debridement and was dressed with a non-absorbent dressing (paraffin gauze). This process was repeated once weekly for 6 weeks.
  arm group label: Conventional therapy
  arm group type: Active Comparator
  description: These patients were treated conservatively by compression using graduated elastic stockings below the knee and dressing using saline and vaseline gauze weekly for 6 weeks.
  intervention type: Biological
  intervention name: PRP
  description: PRP is a volume of autologous plasma that has a platelet concentration above baseline i.e., five times more than normal platelet counts. PRP enhances wound healing by promoting the healing process by seven growth factors present in it. They are platelet derived growth factor (αα, αβ, αβ), fibroblast growth factor, vascular endothelial growth factor, epidermal growth factor, transforming growth factor.
  arm group label: Platelet-rich plasma
  intervention type: Other
  intervention name: Conventional therapy
  description: Conventional therapy
  arm group label: Conventional therapy
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Rabia Ghafoor
  role: Study Director
  affiliation: Jinnah Post Graduate Medical Centre
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Jinnah Postgraduate Medical Centre
  investigator full name: Faiza Inam Siddiqui
  investigator title: Resident dermatologist (fcps)
  mesh term: Varicose Ulcer
  mesh term: Leg Ulcer
  mesh term: Ulcer