<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/NCT01679678</url>
  </required_header>
  <id_info>
    <org_study_id>MWPH-2012-08-01</org_study_id>
    <nct_id>NCT01679678</nct_id>
  </id_info>
  <brief_title>A Study, Performed in Subjects With Post Traumatic-post Surgical ,Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of PolyHeal-2 Versus PolyHeal in Once Daily Regimen</brief_title>
  <official_title>A Double Blind, Randomized, Controlled Study, Performed in Subjects With Post Traumatic-post Surgical, Venus Insufficiency and Diabetic Hard to Heal/Chronic Wounds, to Evaluate the Safety and Efficacy of Polyheal-2 vs PolyHeal in Once Daily Regimen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MediWound Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MediWound Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety&#xD;
      and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical&#xD;
      control. The study will enroll adult subjects with post traumatic/post surgical, venus&#xD;
      insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be&#xD;
      followed for 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will undergo screenibg period of up to two weeks. Following to eligibilidy&#xD;
      confirmation subjects will be randomized into one of the two treatment groups and treated&#xD;
      with study device once daily for 4 weeks.&#xD;
&#xD;
      Continuation of study device for additional period is based on wound healing progression and&#xD;
      under investigator's discretion.&#xD;
&#xD;
      Subjects will be followed up weekly following to 4 weeks of active treatment for additional 8&#xD;
      weeks untol week 12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business considerations&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase)</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Surgical Wound Dehiscence</condition>
  <arm_group>
    <arm_group_label>PolyHeal 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Negatively charged 5-micron polystyrene microspheres in Water For Injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PolyHeal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PolyHeal 2</intervention_name>
    <description>PolyHeal is a sterile medical device</description>
    <arm_group_label>PolyHeal 2</arm_group_label>
    <other_name>PolyHeal</other_name>
    <other_name>PolyHeal is a sterile medical device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Polyheal</intervention_name>
    <description>PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in</description>
    <arm_group_label>PolyHeal</arm_group_label>
    <other_name>PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in DMEM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hard to heal/chronic post traumatic post surgical ,venus insufficiency and diabetic&#xD;
             wound refractory to healing at least 4 weeks prior to study treatment (one or more&#xD;
             target wound/s will be eligible per each subject to be treated by the same agent)&#xD;
&#xD;
          -  Subjects who are able to read, understand, and sign the informed consent form. In case&#xD;
             of compromised mental capacity, approval and signature of a legal guardian is&#xD;
             required.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of a systemic infection or significant local infection with copious purulent&#xD;
             drainage, fluids drainage, gangrene, or cellulites, or necrosis at the target wound&#xD;
             site, as well as nonviable tissue, sinus tracts or tunnels that cannot be removed by&#xD;
             debridement.&#xD;
&#xD;
          -  Wounds with exposed bones, tendons or ligaments&#xD;
&#xD;
          -  Wounds with exposed orthopedic implants&#xD;
&#xD;
          -  Wounds with exposed breast prostheses&#xD;
&#xD;
          -  Uncontrolled diabetes with HbA1c &gt;11%&#xD;
&#xD;
          -  Subjects with BMI greater than 35kg/m2&#xD;
&#xD;
          -  Woman who are pregnant or nursing, or of childbearing potential and are not using&#xD;
             adequate contraception&#xD;
&#xD;
          -  Participation in another clinical drug/device trial within 30 days prior to the&#xD;
             Screening visit or during this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alex Berezovsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Department of Plastic and reconstructive surgery</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eyal Gur, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leonid Kogan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Plastic Surgery Department Western Galilee Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yehuda Ulman, Proffesor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Plastic surgery department ,Rambam Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Soroka Medical Center</name>
      <address>
        <city>Beer Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Galilee Hospital</name>
      <address>
        <city>Naharia</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Souraski Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>March 29, 2016</last_update_submitted>
  <last_update_submitted_qc>March 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Dehiscence</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</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/NCT01679678
org study id: MWPH-2012-08-01
nct id: NCT01679678
lead sponsor: 
has dmc: No
This is a double-blind , randomized, controlled, two-arm study aiming to evaluate the safety
      and efficacy of Polyheal-2 vs PolyHeal, in once daily application as compared to historical
      control. The study will enroll adult subjects with post traumatic/post surgical, venus
      insufficiency and diabetic hard to heal wounds who meet the entrance criteria which will be
      followed for 12 weeks.
Subjects will undergo screenibg period of up to two weeks. Following to eligibilidy
      confirmation subjects will be randomized into one of the two treatment groups and treated
      with study device once daily for 4 weeks.

      Continuation of study device for additional period is based on wound healing progression and
      under investigator's discretion.

      Subjects will be followed up weekly following to 4 weeks of active treatment for additional 8
      weeks untol week 12.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Achievement of at least (≥)75% viable granulation tissue (grade 7 or 8 on the granulometer scale) after 4 weeks of study treatment (active phase)
time frame: 4 weeks
arm group label: PolyHeal 2
arm group type: Experimental
description: Negatively charged 5-micron polystyrene microspheres in Water For Injection
arm group label: PolyHeal
arm group type: Active Comparator
description: Negatively charged 5-micron polystyrene microspheres suspended in Dulbecco's Modified Eagle's Medium (DMEM)
intervention type: Device
intervention name: PolyHeal 2
description: PolyHeal is a sterile medical device
arm group label: PolyHeal 2
other name: PolyHeal
other name: PolyHeal is a sterile medical device
intervention type: Device
intervention name: Polyheal
description: PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in
arm group label: PolyHeal
other name: PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in DMEM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Alex Berezovsky, MD
role: Principal Investigator
affiliation: Head of Department of Plastic and reconstructive surgery
last name: Eyal Gur, MD
role: Principal Investigator
affiliation: Head of Plastic and Reconstructive Surgery Department, Souraski Medical Center
last name: Leonid Kogan, MD
role: Principal Investigator
affiliation: Head of Plastic Surgery Department Western Galilee Hospital
last name: Yehuda Ulman, Proffesor
role: Principal Investigator
affiliation: Head of Plastic surgery department ,Rambam Medical Center
facility: 
facility: 
facility: 
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Surgical Wound Dehiscence
mesh term: Wounds and Injuries
mesh term: Surgical Wound