<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/NCT01734109</url>
  </required_header>
  <id_info>
    <org_study_id>ITIQ002A</org_study_id>
    <nct_id>NCT01734109</nct_id>
  </id_info>
  <brief_title>Efficacy of Quantum NPWT With Simultaneous Irrigation on Reduction of Wound Volume in Stage III/IV Pressure Ulcers.</brief_title>
  <official_title>A 12-week, Single Site, Randomized Controlled Trial to Compare the Efficacy of Quantum NPWT With and Without Simultaneous Irrigation Versus Standard of Care on Reduction of the Volume of Stage III/IV Pressure Ulcers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innovative Therapies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Innovative Therapies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and&#xD;
      promotes granulation tissue and angiogenesis. Despite these known means for facilitation of&#xD;
      wound management, further research is needed to examine whether this modality is superior to&#xD;
      other currently used options, thus defining clear indications for and benefits of NPWT. This&#xD;
      would also help establish the role of combination therapy, using NPWT with simultaneous&#xD;
      irrigation or other forms of dressings. This study aims to compare treatment efficacy of&#xD;
      NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of&#xD;
      care for treatment of grade III &amp; IV pressure ulcers. Primary endpoint of this study is&#xD;
      comparison of reduction of wound volume between the three treatment arms; and secondary&#xD;
      endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">March 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <phase>Phase 4</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>Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care</measure>
    <time_frame>12-weeks</time_frame>
    <description>Comparison of reduction in wound volume between Quantum with Irrigation versus standard of care over 12 weeks treatment period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of reduction in wound volume between Quantum with Irrigation v Quantum without irrigation</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparison of reduction in wound volume between Quantum with Irrigation versus Quantum without irrigation over 12 weeks measurement period.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain</measure>
    <time_frame>12 weeks</time_frame>
    <description>Weekly assessment of pain using standard VAS.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Pressure Ulcers</condition>
  <arm_group>
    <arm_group_label>Standard of Care - Wound Care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard, acceptable local wound care management, consisting of topical treatments, chemical debriders, or light bedside debridement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quantum NPWT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention with Quantum NPWT to Standard III/IV pressure ulcers for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quantum NPWT with Irrigation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NPWT with the Quantum device, with the addition of simultaneous irrigation using 0.25% acetic acid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Quantum Negative Pressure Wound Therapy Device</intervention_name>
    <description>To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.</description>
    <arm_group_label>Quantum NPWT</arm_group_label>
    <arm_group_label>Quantum NPWT with Irrigation</arm_group_label>
    <other_name>Quantum NPWT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female between the ages of 18 and 70&#xD;
&#xD;
          -  Any patient with a stage III/IV pressure ulcer of the size large enough to indicate&#xD;
             use of Negative Pressure Treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical evidence of active, gross infection.&#xD;
&#xD;
          -  Patient or patient's guardian refuses consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra J Berriman, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Innovative Therapies, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kenneth Moquin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Hospital System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kenneth Moquin, MD</last_name>
    <phone>734-301-1083</phone>
    <email>kmoquin1@hfhs.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nadia Obeid, MD</last_name>
    <phone>248-709-0067</phone>
    <email>nobeid1@hfhs.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Henry Ford Hospital System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <investigator>
      <last_name>Kenneth Moquin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 27, 2012</last_update_submitted>
  <last_update_submitted_qc>November 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Negative Pressure Wound Therapy</keyword>
  <keyword>Irrigation Therapy</keyword>
  <keyword>Pressure Ulcers</keyword>
  <keyword>Sacral Ulcers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
    <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/NCT01734109
org study id: ITIQ002A
nct id: NCT01734109
lead sponsor: 
has dmc: No
Negative-pressure wound therapy (NPWT) is an important adjunct for management of wounds, and
      promotes granulation tissue and angiogenesis. Despite these known means for facilitation of
      wound management, further research is needed to examine whether this modality is superior to
      other currently used options, thus defining clear indications for and benefits of NPWT. This
      would also help establish the role of combination therapy, using NPWT with simultaneous
      irrigation or other forms of dressings. This study aims to compare treatment efficacy of
      NPWT, NPWT plus proprietary simultaneous irrigation, and traditional hospital standard of
      care for treatment of grade III & IV pressure ulcers. Primary endpoint of this study is
      comparison of reduction of wound volume between the three treatment arms; and secondary
      endpoints include bacterial load, rate of wound healing, preparation for grafting, and pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparison of reduction in wound volume between Quantum with Irrigation v Standard of Care
time frame: 12-weeks
description: Comparison of reduction in wound volume between Quantum with Irrigation versus standard of care over 12 weeks treatment period.
measure: Comparison of reduction in wound volume between Quantum with Irrigation v Quantum without irrigation
time frame: 12 weeks
description: Comparison of reduction in wound volume between Quantum with Irrigation versus Quantum without irrigation over 12 weeks measurement period.
measure: Pain
time frame: 12 weeks
description: Weekly assessment of pain using standard VAS.
arm group label: Standard of Care - Wound Care
arm group type: Placebo Comparator
description: Standard, acceptable local wound care management, consisting of topical treatments, chemical debriders, or light bedside debridement.
arm group label: Quantum NPWT
arm group type: Active Comparator
description: Intervention with Quantum NPWT to Standard III/IV pressure ulcers for 12 weeks.
arm group label: Quantum NPWT with Irrigation
arm group type: Active Comparator
description: NPWT with the Quantum device, with the addition of simultaneous irrigation using 0.25% acetic acid.
intervention type: Device
intervention name: Quantum Negative Pressure Wound Therapy Device
description: To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.
arm group label: Quantum NPWT
arm group label: Quantum NPWT with Irrigation
other name: Quantum NPWT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Sandra J Berriman, Ph.D.
role: Study Director
affiliation: Innovative Therapies, Inc.
last name: Kenneth Moquin, MD
role: Principal Investigator
affiliation: Henry Ford Hospital System
last name: Kenneth Moquin, MD
phone: 734-301-1083
email: kmoquin1@hfhs.org
last name: Nadia Obeid, MD
phone: 248-709-0067
email: nobeid1@hfhs.org
facility: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Pressure Ulcer
mesh term: Ulcer