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/NCT06024590</url>
    </required_header>
    <id_info>
      <org_study_id>NIFAS-2023-001</org_study_id>
      <nct_id>NCT06024590</nct_id>
    </id_info>
    <brief_title>Outcomes of Irrisept Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers</brief_title>
    <official_title>Outcomes of Chlorhexidine Gluconate Irrigation as an Adjunctive Treatment in the Management of Diabetic Foot Ulcers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Northern Illinois Foot and Ankle Specialists</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Irrimax Corporation</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Northern Illinois Foot and Ankle Specialists</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Irrisept™ irrigation containing Chlorhexidine Gluconate (CHG) 0.05% in sterile water, is an&#xD;
        irrigation method that may help reduce bacterial load considerably more than traditional&#xD;
        saline irrigation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this clinical evaluation is to collect patient outcome data on Irrisept™&#xD;
        irrigation. This is a jet irrigation of 0.05% Chlorhexidine Gluconate (CHG) in sterile water&#xD;
        delivered under pressure by manual compression of the bottle by the user. This treatment&#xD;
        allows for management of bioburden in a wound through broad spectrum antimicrobial activity&#xD;
        by the CHG as well as removal of debris from the wound bed.&#xD;
  &#xD;
        In this trial, participants with partial and full thickness diabetic foot ulcers (DFUs) -&#xD;
        'full skin thickness and extending through the subcutaneous or fat layers or to deeper&#xD;
        structures such as tendon and fascia will receive standard of care treatment with indicated&#xD;
        off-loading device (SOC) for their condition in addition to wound bed irrigation with&#xD;
        Irrisept™ or saline Irrigation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2024</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>The primary endpoint is the percentage of index ulcers healed at 12 weeks</measure>
      <time_frame>Weekly up to 12 weeks</time_frame>
      <description>Percentage of index ulcers healed from baseline up to 12 weeks</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time: to heal within 12 weeks</measure>
      <time_frame>Weekly up to 12 weeks</time_frame>
      <description>Days to heal from baseline up to 12 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Area Reduction (PAR) at 12 weeks</measure>
      <time_frame>Weekly up to 12 weeks</time_frame>
      <description>Percent Area Reduction (PAR) from baseline up to 12 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain reduction between visits, measured by Visual Analogue Scale (VAS)</measure>
      <time_frame>Weekly up to 12 weeks</time_frame>
      <description>Pain reduction from baseline up to 12 weeks. VAS (0-100 scale; 0 being no discomfort, 100 being intense discomfort)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wound complication rate</measure>
      <time_frame>Weekly up to 12 weeks</time_frame>
      <description>Infection, return to operating room for management or other adverse events during the treatment course.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Diabetic Foot Ulcer</condition>
    <arm_group>
      <arm_group_label>Group A: irrigation with Irrisept™</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group A: standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B: irrigation or irrigation with normal saline</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group B: standard of care wound treatment with 150 mL ration of normal saline irrigation of the wound at each follow up visit.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Irrisept</intervention_name>
      <description>Standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.</description>
      <arm_group_label>Group A: irrigation with Irrisept™</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Saline</intervention_name>
      <description>Standard of care wound treatment with 150 mL ration of Normal saline irrigation of the wound at each follow up visit</description>
      <arm_group_label>Group B: irrigation or irrigation with normal saline</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. At least 18 years old.&#xD;
  &#xD;
            2. Presence of a partial and full thickness DFU extending at least through the dermis and&#xD;
               into the subcutaneous tissue down to the exposed tendon and fascia.&#xD;
  &#xD;
            3. Wounds present anatomically on the foot as defined by beginning below the malleoli of&#xD;
               the ankle, excluding wounds on the heel.&#xD;
  &#xD;
            4. The index ulcer will be the largest ulcer if two or more eligible DFUs are present and&#xD;
               will be the only one evaluated in the study. If other ulcerations are present on the&#xD;
               same foot, they must be more than 2 cm distant from the index ulcer.&#xD;
  &#xD;
            5. Index ulcer (i.e., current episode of ulceration) has been present for greater than 4&#xD;
               weeks prior to first screening visit (SV1) and less than 1 year, as of the date the&#xD;
               subject consents for study.&#xD;
  &#xD;
            6. Adequate circulation to the affected foot as documented by the following: palpable&#xD;
               pedal pulses, pulses audibly biphasic or triphasic with handheld doppler, or recent&#xD;
               (&lt;6 month) vascular testing (both invasive &amp; non-invasive).&#xD;
  &#xD;
            7. Females of childbearing potential must be willing to use acceptable methods of&#xD;
               contraception (birth control pills, barriers or abstinence) during the course of the&#xD;
               study and undergo pregnancy tests.&#xD;
  &#xD;
            8. Subject understands and is willing to participate in the clinical study and can comply&#xD;
               with weekly visits.&#xD;
  &#xD;
            9. Subject understands they can exit the study at any time.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Clinical signs of infection at the start of the study&#xD;
  &#xD;
            2. Exposed bone(s)&#xD;
  &#xD;
            3. Immunocompromised as determined by treating physician&#xD;
  &#xD;
            4. Presence of greater than one full-thickness DFU less than 2 cm apart&#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>Patrick McEneaney, DPM</last_name>
      <role>Principal Investigator</role>
      <affiliation>Northern Illinois Foot &amp; Ankle Specialist</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lori Rotolo, BS</last_name>
      <phone>2168493574</phone>
      <email>lorirotolo@illinoisfoot.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Northern Illinois Foot &amp; Ankle Specialists</name>
        <address>
          <city>Cary</city>
          <state>Illinois</state>
          <zip>60013</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lori Rotolo, BS</last_name>
        <email>lorirotolo@Illinoisfoot.com</email>
      </contact>
      <investigator>
        <last_name>Rimvydas Statkus, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Summer Bochat, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Peter Lovato, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rebecca Stack, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>John Thometz, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Northern Illinois Foot &amp; Ankle Specialists</name>
        <address>
          <city>Crystal Lake</city>
          <state>Illinois</state>
          <zip>60014</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lori Rotolo, BS</last_name>
        <phone>216-849-3574</phone>
        <email>lorirotolo@illinoisfoot.com</email>
      </contact>
      <investigator>
        <last_name>Patrick McEneaney, DPM</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Peter Lovato, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kimberly Nolan, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rebecca Stack, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Summer Bochat, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rimvydas Statkus, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Northern Illinois Foot &amp; Ankle Specialists</name>
        <address>
          <city>Elgin</city>
          <state>Illinois</state>
          <zip>60123</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lori Rotolo, BS</last_name>
        <email>lorirotolo@illinoisfoot.com</email>
      </contact>
      <investigator>
        <last_name>John Thometz, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Northern Illinois Foot &amp; Ankle Specialists</name>
        <address>
          <city>Fox Lake</city>
          <state>Illinois</state>
          <zip>60020</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lori Rotolo, BS</last_name>
        <email>lorirotolo@illinoisfoot.com</email>
      </contact>
      <investigator>
        <last_name>Summer Bochat, DMP</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rimvydas Statkus, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Northern Illinois Foot &amp; Ankle Specialist</name>
        <address>
          <city>Lake In The Hills</city>
          <state>Illinois</state>
          <zip>60156</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lori Rotolo, BS</last_name>
        <phone>216-849-3574</phone>
        <email>lorirotolo@illinoisfoot.com</email>
      </contact>
      <investigator>
        <last_name>Peter Lovato, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Summer Bochat, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rebecca Stack, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>John Thometz, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rimvydas Statkus, DPM</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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>Diabetic Foot</mesh_term>
      <mesh_term>Foot 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/NCT06024590
  org study id: NIFAS-2023-001
  nct id: NCT06024590
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  Irrisept™ irrigation containing Chlorhexidine Gluconate (CHG) 0.05% in sterile water, is an
        irrigation method that may help reduce bacterial load considerably more than traditional
        saline irrigation.
  The purpose of this clinical evaluation is to collect patient outcome data on Irrisept™
        irrigation. This is a jet irrigation of 0.05% Chlorhexidine Gluconate (CHG) in sterile water
        delivered under pressure by manual compression of the bottle by the user. This treatment
        allows for management of bioburden in a wound through broad spectrum antimicrobial activity
        by the CHG as well as removal of debris from the wound bed.
  
        In this trial, participants with partial and full thickness diabetic foot ulcers (DFUs) -
        'full skin thickness and extending through the subcutaneous or fat layers or to deeper
        structures such as tendon and fascia will receive standard of care treatment with indicated
        off-loading device (SOC) for their condition in addition to wound bed irrigation with
        Irrisept™ or saline Irrigation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The primary endpoint is the percentage of index ulcers healed at 12 weeks
  time frame: Weekly up to 12 weeks
  description: Percentage of index ulcers healed from baseline up to 12 weeks
  measure: Time: to heal within 12 weeks
  time frame: Weekly up to 12 weeks
  description: Days to heal from baseline up to 12 weeks
  measure: Percent Area Reduction (PAR) at 12 weeks
  time frame: Weekly up to 12 weeks
  description: Percent Area Reduction (PAR) from baseline up to 12 weeks
  measure: Pain reduction between visits, measured by Visual Analogue Scale (VAS)
  time frame: Weekly up to 12 weeks
  description: Pain reduction from baseline up to 12 weeks. VAS (0-100 scale; 0 being no discomfort, 100 being intense discomfort)
  measure: Wound complication rate
  time frame: Weekly up to 12 weeks
  description: Infection, return to operating room for management or other adverse events during the treatment course.
  arm group label: Group A: irrigation with Irrisept™
  arm group type: Active Comparator
  description: Group A: standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.
  arm group label: Group B: irrigation or irrigation with normal saline
  arm group type: Active Comparator
  description: Group B: standard of care wound treatment with 150 mL ration of normal saline irrigation of the wound at each follow up visit.
  intervention type: Device
  intervention name: Irrisept
  description: Standard of care wound treatment with 150 mL of IrriseptTM irrigation of the wound at each follow up visit.
  arm group label: Group A: irrigation with Irrisept™
  intervention type: Device
  intervention name: Saline
  description: Standard of care wound treatment with 150 mL ration of Normal saline irrigation of the wound at each follow up visit
  arm group label: Group B: irrigation or irrigation with normal saline
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Patrick McEneaney, DPM
  role: Principal Investigator
  affiliation: Northern Illinois Foot & Ankle Specialist
  last name: Lori Rotolo, BS
  phone: 2168493574
  email: lorirotolo@illinoisfoot.com
  facility: 
  contact: 
  investigator: 
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  country: United States
  responsible party type: Sponsor
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  mesh term: Ulcer