<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/NCT02213952</url>
  </required_header>
  <id_info>
    <org_study_id>UIAPB-PRPULCERAS-2014-02</org_study_id>
    <secondary_id>2014-001514-26</secondary_id>
    <nct_id>NCT02213952</nct_id>
  </id_info>
  <brief_title>PRP ULCERAS: Clinical Trial Phase III</brief_title>
  <acronym>PRPULCERAS</acronym>
  <official_title>Efficacy of Autologous Platelet-Rich Plasma in the Treatment of Vascular Ulcers in Primary Care: Clinical Trial Phase III</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Basque Health Service</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Osakidetza</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Basque Health Service</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in all&#xD;
      the assistance levels, and they have big repercussion referring to individual, social and&#xD;
      labour levels, supposing a big consumption of human and material resources.The cure with&#xD;
      autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a&#xD;
      decrease in the cicatrization time comparing to conventional methods in hospital levels,&#xD;
      which becomes interesting contrasting its efficacy in primary care.&#xD;
&#xD;
      AIM:Evaluate the efficacy of the autologous PRP in the treatment of vascular ulcers,&#xD;
      comparing to the conventional treatment ( cure with humid environment), in primary care&#xD;
      patients with chronic venous insufficiency in C-6 degree (CEAP classification).&#xD;
&#xD;
      DESIGN: A study will be executed, which will consist in a randomized clinical test,&#xD;
      multicentered, in parallel groups and opened. 150 patients suffering of venous vascular&#xD;
      ulcers will be studied, who will be between the age of 40-100 years old, and who will be&#xD;
      attached to 10 health centers. Variables for the identification, following, result and&#xD;
      patient profile have been defined. Emphasize the variables of &quot;ulcer area decreasing&quot;, &quot;CIVIQ&#xD;
      index&quot;, &quot;% one cure per week&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vascular ulcers are an important pathology in the daily medical practice in all the&#xD;
      assistance levels, and they have big repercussion referring to individual, social and labour&#xD;
      levels, supposing a big consumption of human and material resources.The cure with autologous&#xD;
      platelet rich plasma (autologous PRP) has demonstrated in different studies a decrease in the&#xD;
      cicatrization time comparing to conventional methods in hospital levels, which becomes&#xD;
      interesting contrasting its efficacy in primary care.The aim of this study is to evaluate the&#xD;
      efficacy of the autologous PRP in the treatment of vascular ulcers, comparing to the&#xD;
      conventional treatment (cure with humid environment), in primary care patients with chronic&#xD;
      venous insufficiency in C-6 degree (CEAP classification). It is a study which will consist in&#xD;
      a randomized clinical test, multicentered, in parallel groups and opened 150 patients&#xD;
      suffering of venous vascular ulcers will be studied. Variables for the identification,&#xD;
      following, result and patient profile have been defined. Emphasize the variables of &quot;ulcer&#xD;
      area change&quot;, &quot;CIVIQ index&quot;, &quot;% one cure per week&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Without recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ULCER SIZE CHANGE</measure>
    <time_frame>Change from baseline at 9 weeks</time_frame>
    <description>Change from baseline at 9 weeks of the surface area of the ulcer, in cm2, measured using ImageJ software from the weekly the photographs of the wound.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QUALITY OF LIFE (INDEX CIVIQ)</measure>
    <time_frame>Change from baseline at 9 weeks</time_frame>
    <description>Change of the CIVIQ SCORE. 20-item self-reported quality of life questionnaire scale called Chronic Venous disease quality of life Questionnaire-20 (CIVIQ-20) was created and validated in France in 1996,1 as a sensitive instrument to capture the key dimensions of quality of life (QoL) specifically impaired by chronic venous disease (CVD). Four dimensions of the CIVIQ-20 were identified: physical (4 items), psychological (9 items), social (3 items), and pain (4 items).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK</measure>
    <time_frame>Change from baseline at 9 weeks</time_frame>
    <description>Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Ulcer</condition>
  <arm_group>
    <arm_group_label>Platelet-Rich Plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Our goal is to evaluate the efficacy of the autologous Platelet-Rich Plasma (PRP) in the treatment of vascular ulcers, comparing to the conventional treatment (cure with humid environment), in primary care patients with chronic venous ulcer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual treatment: Patients in the control group will be treated according to Osakidetza recommendations of humid environment cure. The choice of material for the cure depends on the prior assessment of the wound and surrounding skin, appearance and amount of exudate and the presence or absence of signs of infection. These cures will be performed every 48-72 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Platelet-Rich Plasma</intervention_name>
    <description>For obtaining autologous PRP, will be drawn from 9-30 ml of blood of the patient in sterile tubes containing 4.5 ml of 3.8% sodium citrate. The tubes will be centrifuged for 8 min at 580 Gs to separate the different blood components according to density gradient. After centrifugation, we will aspire the PRP. We will add CaCl2 to the PRP (50l per ml of liquid plasma). While the plasma will get gelified, we will cure the ulcer with saline cleaning and mechanical removal. Then the ulcer will be covered with gelified PRP and a secondary dressing. This cure will be done each 7 days.</description>
    <arm_group_label>Platelet-Rich Plasma</arm_group_label>
    <other_name>PRP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual treatment</intervention_name>
    <description>Usual treatment: Patients in the control group will be treated according to Osakidetza recommendations of humid environment cure. The choice of material for the cure depends on the prior assessment of the wound and surrounding skin, appearance and amount of exudate and the presence or absence of signs of infection. These cures will be performed every 48-72 hours.</description>
    <arm_group_label>Usual treatment</arm_group_label>
    <other_name>Osakidetza protocol of humid environment cure.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients from Barakaldo and Bilbao, who come to the treatment room at health centers&#xD;
             in these towns belong to the OSI Ezkerraldea-Enkarterri-Cruces of Osakidetza-Basque&#xD;
             Health Service.&#xD;
&#xD;
          -  Men or women older than 18 years old.&#xD;
&#xD;
          -  Patients with chronic venous insufficiency stage C-6 of the CEAP classification.&#xD;
&#xD;
          -  Patients with vascular ulcers unresponsive to conventional treatment over a 2 months&#xD;
             period or recurrence of previous venous ulcers.&#xD;
&#xD;
          -  Patients who present an analytical before entering the studio, platelets and red blood&#xD;
             cell count and hematocrit in normal range&#xD;
&#xD;
          -  Ulcers whose diameter size is 30cm² or less.&#xD;
&#xD;
          -  Greater Ankle Arm Index 0.8 and less than 1.5.&#xD;
&#xD;
          -  Patients with recent analytic with number platelet and red blood cell count and&#xD;
             hematocrit normal range.&#xD;
&#xD;
          -  Patients with recent analytic negative to: Syphilis serology, Hepatitis B: HBsAg,&#xD;
             Hepatitis C: Anti-HCV tests genomic nucleic acid amplification (NAT), HIV I / II:&#xD;
             Anti-HIV I / II.&#xD;
&#xD;
          -  Self or family support sufficient to move patients to the health center.&#xD;
&#xD;
          -  Written informed consent of the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on chronic immunosuppressive or retroviral.&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Patients with chronic infectious diseases.&#xD;
&#xD;
          -  Patients treated with radiotherapy or chemotherapy, or history of neoplasia.&#xD;
&#xD;
          -  Patients with more than two active ulcers.&#xD;
&#xD;
          -  Pregnant or childbearing potential not want to use contraception.&#xD;
&#xD;
          -  Women breastfeeding.&#xD;
&#xD;
          -  Patients with active infection or febrile syndrome at baseline.&#xD;
&#xD;
          -  People who are taking a drug under clinical investigation or participated in any study&#xD;
             under clinical investigation in the previous 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kepa Mirena San Sebastian Moreno</last_name>
    <role>Principal Investigator</role>
    <affiliation>C. Ezkerraldea Enkarterri.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Igone Hernández Cabezas.</last_name>
    <role>Study Chair</role>
    <affiliation>C. Ezkerraldea Enkarterri</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Igone Lobato García</last_name>
    <role>Study Chair</role>
    <affiliation>C. Ezkerraldea Enkarterri</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Begoña Rodríguez Rodríguez.</last_name>
    <role>Study Chair</role>
    <affiliation>C. Bilbao</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ariadna Pérez Salvador</last_name>
    <role>Study Chair</role>
    <affiliation>C. Ezkerraldea Enkarterri</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gonzalo Grandes Odriozola</last_name>
    <role>Study Chair</role>
    <affiliation>Primary Care Research Unit of Bizkaia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Natalia Burgos Alonso.</last_name>
    <role>Study Director</role>
    <affiliation>Primary Care Research Unit of Bizkaia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anna Giné March</last_name>
    <role>Study Director</role>
    <affiliation>Primary Care Research Unit of Bizkaia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kepa Mirena San Sebastian Moreno</last_name>
    <role>Principal Investigator</role>
    <affiliation>C. Ezkerraldea Enkarterri</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comarca Enkarterri Ezkerraldea</name>
      <address>
        <city>Portugalete</city>
        <state>Bizakaia</state>
        <zip>48920</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UIAPB</name>
      <address>
        <city>Bilbao</city>
        <state>Bizkaia</state>
        <zip>48014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>February 21, 2020</last_update_submitted>
  <last_update_submitted_qc>February 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Basque Health Service</investigator_affiliation>
    <investigator_full_name>Kepa M. San Sebastián Moreno</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>Ulcer</keyword>
  <keyword>Platelet-Rich Plasma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <!-- 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/NCT02213952
org study id: UIAPB-PRPULCERAS-2014-02
secondary id: 2014-001514-26
nct id: NCT02213952
lead sponsor: 
collaborator: 
has dmc: Yes
INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in all
      the assistance levels, and they have big repercussion referring to individual, social and
      labour levels, supposing a big consumption of human and material resources.The cure with
      autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a
      decrease in the cicatrization time comparing to conventional methods in hospital levels,
      which becomes interesting contrasting its efficacy in primary care.

      AIM:Evaluate the efficacy of the autologous PRP in the treatment of vascular ulcers,
      comparing to the conventional treatment ( cure with humid environment), in primary care
      patients with chronic venous insufficiency in C-6 degree (CEAP classification).

      DESIGN: A study will be executed, which will consist in a randomized clinical test,
      multicentered, in parallel groups and opened. 150 patients suffering of venous vascular
      ulcers will be studied, who will be between the age of 40-100 years old, and who will be
      attached to 10 health centers. Variables for the identification, following, result and
      patient profile have been defined. Emphasize the variables of "ulcer area decreasing", "CIVIQ
      index", "% one cure per week".
Vascular ulcers are an important pathology in the daily medical practice in all the
      assistance levels, and they have big repercussion referring to individual, social and labour
      levels, supposing a big consumption of human and material resources.The cure with autologous
      platelet rich plasma (autologous PRP) has demonstrated in different studies a decrease in the
      cicatrization time comparing to conventional methods in hospital levels, which becomes
      interesting contrasting its efficacy in primary care.The aim of this study is to evaluate the
      efficacy of the autologous PRP in the treatment of vascular ulcers, comparing to the
      conventional treatment (cure with humid environment), in primary care patients with chronic
      venous insufficiency in C-6 degree (CEAP classification). It is a study which will consist in
      a randomized clinical test, multicentered, in parallel groups and opened 150 patients
      suffering of venous vascular ulcers will be studied. Variables for the identification,
      following, result and patient profile have been defined. Emphasize the variables of "ulcer
      area change", "CIVIQ index", "% one cure per week".
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: ULCER SIZE CHANGE
time frame: Change from baseline at 9 weeks
description: Change from baseline at 9 weeks of the surface area of the ulcer, in cm2, measured using ImageJ software from the weekly the photographs of the wound.
measure: QUALITY OF LIFE (INDEX CIVIQ)
time frame: Change from baseline at 9 weeks
description: Change of the CIVIQ SCORE. 20-item self-reported quality of life questionnaire scale called Chronic Venous disease quality of life Questionnaire-20 (CIVIQ-20) was created and validated in France in 1996,1 as a sensitive instrument to capture the key dimensions of quality of life (QoL) specifically impaired by chronic venous disease (CVD). Four dimensions of the CIVIQ-20 were identified: physical (4 items), psychological (9 items), social (3 items), and pain (4 items).
measure: Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK
time frame: Change from baseline at 9 weeks
description: Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK
arm group label: Platelet-Rich Plasma
arm group type: Experimental
description: Our goal is to evaluate the efficacy of the autologous Platelet-Rich Plasma (PRP) in the treatment of vascular ulcers, comparing to the conventional treatment (cure with humid environment), in primary care patients with chronic venous ulcer.
arm group label: Usual treatment
arm group type: Active Comparator
description: Usual treatment: Patients in the control group will be treated according to Osakidetza recommendations of humid environment cure. The choice of material for the cure depends on the prior assessment of the wound and surrounding skin, appearance and amount of exudate and the presence or absence of signs of infection. These cures will be performed every 48-72 hours.
intervention type: Drug
intervention name: Platelet-Rich Plasma
description: For obtaining autologous PRP, will be drawn from 9-30 ml of blood of the patient in sterile tubes containing 4.5 ml of 3.8% sodium citrate. The tubes will be centrifuged for 8 min at 580 Gs to separate the different blood components according to density gradient. After centrifugation, we will aspire the PRP. We will add CaCl2 to the PRP (50l per ml of liquid plasma). While the plasma will get gelified, we will cure the ulcer with saline cleaning and mechanical removal. Then the ulcer will be covered with gelified PRP and a secondary dressing. This cure will be done each 7 days.
arm group label: Platelet-Rich Plasma
other name: PRP
intervention type: Other
intervention name: Usual treatment
description: Usual treatment: Patients in the control group will be treated according to Osakidetza recommendations of humid environment cure. The choice of material for the cure depends on the prior assessment of the wound and surrounding skin, appearance and amount of exudate and the presence or absence of signs of infection. These cures will be performed every 48-72 hours.
arm group label: Usual treatment
other name: Osakidetza protocol of humid environment cure.
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Kepa Mirena San Sebastian Moreno
role: Principal Investigator
affiliation: C. Ezkerraldea Enkarterri.
last name: Igone Hernández Cabezas.
role: Study Chair
affiliation: C. Ezkerraldea Enkarterri
last name: Igone Lobato García
role: Study Chair
affiliation: C. Ezkerraldea Enkarterri
last name: Begoña Rodríguez Rodríguez.
role: Study Chair
affiliation: C. Bilbao
last name: Ariadna Pérez Salvador
role: Study Chair
affiliation: C. Ezkerraldea Enkarterri
last name: Gonzalo Grandes Odriozola
role: Study Chair
affiliation: Primary Care Research Unit of Bizkaia
last name: Natalia Burgos Alonso.
role: Study Director
affiliation: Primary Care Research Unit of Bizkaia
last name: Anna Giné March
role: Study Director
affiliation: Primary Care Research Unit of Bizkaia
last name: Kepa Mirena San Sebastian Moreno
role: Principal Investigator
affiliation: C. Ezkerraldea Enkarterri
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Basque Health Service
investigator full name: Kepa M. San Sebastián Moreno
investigator title: Physician
mesh term: Ulcer