<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/NCT03286452</url>
  </required_header>
  <id_info>
    <org_study_id>16-REG-002-PPAM</org_study_id>
    <nct_id>NCT03286452</nct_id>
  </id_info>
  <brief_title>The RESPOND Registry</brief_title>
  <acronym>RESPOND</acronym>
  <official_title>Real-World Effectiveness Study of PuraPly™ AM on Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Organogenesis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Continuum Clinical Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Organogenesis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the&#xD;
      management of wounds in real world clinical settings; no experimental intervention is&#xD;
      involved.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to assess the impact of PuraPly™ AM on the management of wounds&#xD;
      in real world clinical settings as it leads to an improvement in wound bed condition (i.e&#xD;
      increase in healthy granulation tissue, reduction in bioburden, and reduction in amount of&#xD;
      exudate).&#xD;
&#xD;
      The RESPOND Registry is a prospective, non-interventional research initiative to collect&#xD;
      information on patients who are eligible to receive PuraPly™ AM, and no interventional&#xD;
      procedures will be mandated by this protocol.&#xD;
&#xD;
      Enrolled and eligible patients will receive standard wound care clinical assessments and any&#xD;
      additional care as determined by the treating wound care clinician. Although multiple wounds&#xD;
      may be treated simultaneously, one wound will be identified as the target wound, and&#xD;
      characteristics regarding this wound will be consistently documented.&#xD;
&#xD;
      The case series is being undertaken to better understand PuraPly™ AM utilization and&#xD;
      subsequent healing outcomes as well as to evaluate the effects of concomitant wound therapy&#xD;
      on healing. Patient's participation may involve follow-up for up to 24 weeks following&#xD;
      application of PuraPly™ AM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">January 26, 2019</completion_date>
  <primary_completion_date type="Actual">July 15, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>24 Weeks</target_duration>
  <primary_outcome>
    <measure>Reduction in size of wound area</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>As measured from change in size from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to complete wound closure</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>As measured by time to complete wound closure from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement in wound bed condition</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>As measured from change in status from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in patient reported pain</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in patient reported quality of life</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>As measured by change in status from baseline as assessed by the SF-12 QoL.</description>
  </secondary_outcome>
  <enrollment type="Actual">310</enrollment>
  <condition>Partial Thickness Wound</condition>
  <condition>Pressure Ulcer</condition>
  <condition>Venous Ulcer</condition>
  <condition>Diabetic Ulcer</condition>
  <condition>Surgical Wounds</condition>
  <condition>Trauma Wounds</condition>
  <condition>Draining Wounds</condition>
  <condition>Chronic Vascular Ulcer</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PuraPly™ Antimicrobial Wound Matrix</intervention_name>
    <description>PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds.</description>
    <other_name>PuraPly™ Antimicrobial</other_name>
    <other_name>PuraPly™ AM</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 300 patients to be enrolled by approximately 30 US-based Physician&#xD;
        Investigators. Patients are male or female at least 18 years old, with an eligible target&#xD;
        wound that meets the Investigator's wound specific treatment goals; including the&#xD;
        management of bioburden, support of granulation tissue formation, and support of wound&#xD;
        closure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is at least 18 years of age.&#xD;
&#xD;
          -  Patient, or their legally authorized representative (LAR), has read, understood and&#xD;
             signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).&#xD;
&#xD;
          -  Patient has a wound appropriate for receiving PuraPly™ AM, including:&#xD;
&#xD;
               -  Partial or full-thickness wound&#xD;
&#xD;
               -  Pressure ulcer&#xD;
&#xD;
               -  Venous ulcer&#xD;
&#xD;
               -  Diabetic ulcer&#xD;
&#xD;
               -  Chronic vascular ulcer&#xD;
&#xD;
               -  Tunneled/undermined wound&#xD;
&#xD;
               -  Surgical wound (e.g., donor sites/graft, post-Mohs' surgery, post-laser surgery,&#xD;
                  podiatric surgery wound, wound dehiscence)&#xD;
&#xD;
               -  Trauma wound (abrasions, lacerations, second degree burns, and skin tears)&#xD;
&#xD;
               -  Draining wound&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has a known sensitivity to porcine materials.&#xD;
&#xD;
          -  Patient has a third-degree burn.&#xD;
&#xD;
          -  Patient has a known sensitivity to polyhexamethylenebiguanide hydrochloride (PHMB).&#xD;
&#xD;
          -  Patient's target wound was previously treated with PuraPly™ AM.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam J Teichman, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>PA Foot and Ankle Association</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shaun Carpenter, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wound Care Associates, LLC.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel L Kapp, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jupiter Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kerry Thibodeaux, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Opelousas General Hospital Wound Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>George Koullias, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southampton Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raymond Abdo, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Louis Foot and Ankle</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Barry Wisler, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Robert Wood Johnson Hamilton</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carlos Trabanco, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Gables Rehabilitation Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ifat Kamin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amanda Estapa, NP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Advanced Wound Healing; Northshore Specialty Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Menack, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CentraState Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ritu Gothwal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Advanced Wound Care Center at Yavapai Regional Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Iafrati, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paula Pons, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Joseph's Center for Wound Care and Hyperbaric Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Taysha Howell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oklahoma Wound Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Allan Grossman, DPM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harrisburg Foot and Ankle Center, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advanced Wound Care Center at Yavapai Regional Medical Center</name>
      <address>
        <city>Prescott Valley</city>
        <state>Arizona</state>
        <zip>86314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jupiter Medical Center</name>
      <address>
        <city>Jupiter</city>
        <state>Florida</state>
        <zip>33458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Gables Rehab Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Advanced Wound Healing; Northshore Specialty Hospital</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wound Care Associates, LLC.</name>
      <address>
        <city>Hammond</city>
        <state>Louisiana</state>
        <zip>70403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Opelousas General Hospital Wound Center</name>
      <address>
        <city>Opelousas</city>
        <state>Louisiana</state>
        <zip>70570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis Foot and Ankle</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CentraState Medical Center</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert Wood Johnson Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>New Jersey</state>
        <zip>08690</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton Hospital</name>
      <address>
        <city>Southampton</city>
        <state>New York</state>
        <zip>11968</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne Memorial Hospital</name>
      <address>
        <city>Goldsboro</city>
        <state>North Carolina</state>
        <zip>27534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacred Heart Hospital</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrisburg Foot and Ankle Center, Inc.</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greensville Health System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Antimicrobial</keyword>
  <keyword>Collagen</keyword>
  <keyword>Bioburden</keyword>
  <keyword>Biofilm</keyword>
  <keyword>PHMB</keyword>
  <keyword>Chronic wounds</keyword>
  <keyword>Acute wounds</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Infective Agents</mesh_term>
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_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/NCT03286452
org study id: 16-REG-002-PPAM
nct id: NCT03286452
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the
      management of wounds in real world clinical settings; no experimental intervention is
      involved.
The purpose of this study is to assess the impact of PuraPly™ AM on the management of wounds
      in real world clinical settings as it leads to an improvement in wound bed condition (i.e
      increase in healthy granulation tissue, reduction in bioburden, and reduction in amount of
      exudate).

      The RESPOND Registry is a prospective, non-interventional research initiative to collect
      information on patients who are eligible to receive PuraPly™ AM, and no interventional
      procedures will be mandated by this protocol.

      Enrolled and eligible patients will receive standard wound care clinical assessments and any
      additional care as determined by the treating wound care clinician. Although multiple wounds
      may be treated simultaneously, one wound will be identified as the target wound, and
      characteristics regarding this wound will be consistently documented.

      The case series is being undertaken to better understand PuraPly™ AM utilization and
      subsequent healing outcomes as well as to evaluate the effects of concomitant wound therapy
      on healing. Patient's participation may involve follow-up for up to 24 weeks following
      application of PuraPly™ AM.
observational model: Case-Only
time perspective: Prospective
measure: Reduction in size of wound area
time frame: Up to 24 weeks
description: As measured from change in size from baseline
measure: Time to complete wound closure
time frame: Up to 24 weeks
description: As measured by time to complete wound closure from baseline
measure: Improvement in wound bed condition
time frame: Up to 24 weeks
description: As measured from change in status from baseline
measure: Improvement in patient reported pain
time frame: Up to 24 weeks
description: As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)
measure: Improvement in patient reported quality of life
time frame: Up to 24 weeks
description: As measured by change in status from baseline as assessed by the SF-12 QoL.
intervention type: Device
intervention name: PuraPly™ Antimicrobial Wound Matrix
description: PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds.
other name: PuraPly™ Antimicrobial
other name: PuraPly™ AM
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adam J Teichman, DPM
role: Principal Investigator
affiliation: PA Foot and Ankle Association
last name: Shaun Carpenter, M.D.
role: Principal Investigator
affiliation: Wound Care Associates, LLC.
last name: Daniel L Kapp, M.D.
role: Principal Investigator
affiliation: Jupiter Medical Center
last name: Kerry Thibodeaux, M.D.
role: Principal Investigator
affiliation: Opelousas General Hospital Wound Center
last name: George Koullias, M.D.
role: Principal Investigator
affiliation: Southampton Hospital
last name: Raymond Abdo, DPM
role: Principal Investigator
affiliation: Saint Louis Foot and Ankle
last name: Barry Wisler, DPM
role: Principal Investigator
affiliation: Robert Wood Johnson Hamilton
last name: Carlos Trabanco, MD
role: Principal Investigator
affiliation: West Gables Rehabilitation Hospital
last name: Ifat Kamin, MD
role: Principal Investigator
affiliation: Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute
last name: Amanda Estapa, NP
role: Principal Investigator
affiliation: Institute for Advanced Wound Healing; Northshore Specialty Hospital
last name: Michael Menack, MD
role: Principal Investigator
affiliation: CentraState Medical Center
last name: Ritu Gothwal, MD
role: Principal Investigator
affiliation: Advanced Wound Care Center at Yavapai Regional Medical Center
last name: Mark Iafrati, MD
role: Principal Investigator
affiliation: Tufts Medical Center
last name: Paula Pons, MD
role: Principal Investigator
affiliation: Saint Joseph's Center for Wound Care and Hyperbaric Medicine
last name: Taysha Howell, MD
role: Principal Investigator
affiliation: Oklahoma Wound Center
last name: Allan Grossman, DPM
role: Principal Investigator
affiliation: Harrisburg Foot and Ankle Center, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Varicose Ulcer
mesh term: Pressure Ulcer
mesh term: Ulcer
mesh term: Wounds and Injuries
mesh term: Surgical Wound
mesh term: Anti-Infective Agents
mesh term: Anti-Bacterial Agents
sharing ipd: Undecided