<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/NCT04437537</url>
  </required_header>
  <id_info>
    <org_study_id>PWMDFUMB2020-1</org_study_id>
    <nct_id>NCT04437537</nct_id>
  </id_info>
  <brief_title>Pilot Study of PHOENIX Impact on Wound Microbiome</brief_title>
  <official_title>A Pilot Study to Determine the Impact of the PHOENIX Wound Matrix® on the Wound Microbiome in Chronic Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenovoDerm</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nanofiber Solutions</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Pilot Study to Determine the Impact of the Phoenix Wound Matrix® on the Wound Microbiome in&#xD;
      Chronic Diabetic Foot Ulcers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The PHOENIX Wound Matrix® (PHOENIX) is a novel, fully synthetic, fully bioabsorbable advanced&#xD;
      wound care device that provides a temporary microenvironment to support endogenous wound&#xD;
      healing, allowing for the regeneration of functional, native tissue in the defect space/wound&#xD;
      bed. As PHOENIX degrades, the pH of the local wound environment is lowered.&#xD;
&#xD;
      In this pilot study, the investigators will examine the microbiome of chronic diabetic foot&#xD;
      ulcers from ten subjects prior to treatment with PHOENIX Wound Matrix® (PHOENIX) and one week&#xD;
      following treatment with PHOENIX.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">May 15, 2022</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Wound Microbiome</measure>
    <time_frame>1 week</time_frame>
    <description>Analysis of the wound microbiome in subjects with chronic DFUs prior to PHOENIX application and 1 week post PHOENIX application:&#xD;
This analysis will identify and quantify the bacterial and fungal microorganisms present in the wound bed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound pH</measure>
    <time_frame>1 week</time_frame>
    <description>Analysis of the wound bed pH prior to PHOENIX application and 1 week post PHOENIX application.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <arm_group>
    <arm_group_label>Pilot Group</arm_group_label>
    <description>Ten subjects with a DFU non-responsive to standard of care for a minimum of treatment period of 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PHOENIX Wound Matrix</intervention_name>
    <description>PHOENIX Wound Matrix will be applied to each subject's DFU following debridement.</description>
    <arm_group_label>Pilot Group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Wound tissue and exudate samples in subjects with a chronic diabetic foot ulcer (DFU) will be&#xD;
      collected and analyzed.&#xD;
&#xD;
      All 10 subjects enrolled in this study will receive the same intervention.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with a DFU non-responsive to standard of care for a minimum of treatment period of&#xD;
        28 days.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Informed Consent Form is signed and dated prior to any study-related activities.&#xD;
&#xD;
          2. 18 years of age or older.&#xD;
&#xD;
          3. Type 1 or type 2 diabetes mellitus.&#xD;
&#xD;
          4. Negative serum pregnancy test at screening for female participants of child-bearing&#xD;
             potential.&#xD;
&#xD;
          5. At least one DFU that meet the following criteria:&#xD;
&#xD;
               1. Ulcer was diagnosed as a partial- or full-thickness DFU that is located distal to&#xD;
                  the malleolus (excluding ulcers between the toes but including those of the heel)&#xD;
&#xD;
               2. Minimum 2-cm margin between the qualifying study ulcer and any other ulcers on&#xD;
                  the specified foot (post-debridement).&#xD;
&#xD;
               3. Wagner grade 1 or 2; or Wagner grade 3 with resolved abscess or osteomyelitis&#xD;
                  (confirmed by plain x-ray, bone biopsy, magnetic resonance imaging or bone scan)&#xD;
                  or resolved joint sepsis.&#xD;
&#xD;
               4. Duration of the study ulcer is a minimum of 4 weeks at the time of the study&#xD;
                  Visit 1.&#xD;
&#xD;
               5. Study ulcer has no clinical features of infection - no elevated bacterial or&#xD;
                  fungal load, nor at least 2 of the following: pain, redness, purulence, swelling,&#xD;
                  warmth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of signs and symptoms of infection at the index ulcer site or affected limb,&#xD;
             including but not limited to cellulitis, osteomyelitis, excessive exudate, gangrene or&#xD;
             deep tissue infection.&#xD;
&#xD;
          2. Positive serum pregnancy test at screening for female participants of child-bearing&#xD;
             potential.&#xD;
&#xD;
          3. Previous treatment with PHOENIX Wound Matrix.&#xD;
&#xD;
          4. Participation in another clinical trial involving a device or systematically&#xD;
             administered investigational study drug or treatment within 30 days of Visit 1 of this&#xD;
             Study.&#xD;
&#xD;
          5. Receiving or scheduled to receive a medication or treatment which, in the opinion of&#xD;
             the Investigator, is known to interfere with, or affect, the rate and quality of wound&#xD;
             healing.&#xD;
&#xD;
          6. History of bone cancer or metastatic disease of the affected limb, radiation therapy&#xD;
             to the foot, or chemotherapy within the 12 months prior to randomization.&#xD;
&#xD;
          7. Treatment with wound dressings that include growth factors, engineered tissues, or&#xD;
             skin substitutes within 30 of Study Visit 1 or scheduled to receive such treatment&#xD;
             during the Study.&#xD;
&#xD;
          8. Edema or lymphedema non-responsive to the standard of care.&#xD;
&#xD;
          9. Treatment with hyperbaric oxygen within 5 days of screening or scheduled to receive&#xD;
             this treatment during the Study&#xD;
&#xD;
         10. History of or intercurrent illnesses or conditions (other than diabetes) that would&#xD;
             compromise the safety of the subject, or the normal wound healing process (i.e., end&#xD;
             stage renal disease, immunosuppression, AIDS, bleeding disorders, etc.)&#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>Alisha Oropallo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sally Kaplan, RN CCRC</last_name>
    <phone>516-233-3600</phone>
    <email>skaplan2@northwell.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Northwell Health Comprehensive Wound Care Center</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Sally Kaplan, RN CCRC</last_name>
      <phone>516-233-3600</phone>
      <email>skaplan2@northwell.edu</email>
    </contact>
    <investigator>
      <last_name>Alisha Oropallo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>October 13, 2021</last_update_submitted>
  <last_update_submitted_qc>October 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Foot Ulcer</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</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/NCT04437537
org study id: PWMDFUMB2020-1
nct id: NCT04437537
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
A Pilot Study to Determine the Impact of the Phoenix Wound Matrix® on the Wound Microbiome in
      Chronic Diabetic Foot Ulcers
The PHOENIX Wound Matrix® (PHOENIX) is a novel, fully synthetic, fully bioabsorbable advanced
      wound care device that provides a temporary microenvironment to support endogenous wound
      healing, allowing for the regeneration of functional, native tissue in the defect space/wound
      bed. As PHOENIX degrades, the pH of the local wound environment is lowered.

      In this pilot study, the investigators will examine the microbiome of chronic diabetic foot
      ulcers from ten subjects prior to treatment with PHOENIX Wound Matrix® (PHOENIX) and one week
      following treatment with PHOENIX.
observational model: Case-Only
time perspective: Prospective
measure: Wound Microbiome
time frame: 1 week
description: Analysis of the wound microbiome in subjects with chronic DFUs prior to PHOENIX application and 1 week post PHOENIX application:
This analysis will identify and quantify the bacterial and fungal microorganisms present in the wound bed.
measure: Wound pH
time frame: 1 week
description: Analysis of the wound bed pH prior to PHOENIX application and 1 week post PHOENIX application.
arm group label: Pilot Group
description: Ten subjects with a DFU non-responsive to standard of care for a minimum of treatment period of 28 days.
intervention type: Device
intervention name: PHOENIX Wound Matrix
description: PHOENIX Wound Matrix will be applied to each subject's DFU following debridement.
arm group label: Pilot Group
Wound tissue and exudate samples in subjects with a chronic diabetic foot ulcer (DFU) will be
      collected and analyzed.

      All 10 subjects enrolled in this study will receive the same intervention.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alisha Oropallo, MD
role: Principal Investigator
affiliation: Northwell Health
last name: Sally Kaplan, RN CCRC
phone: 516-233-3600
email: skaplan2@northwell.edu
facility: 
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: No