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/NCT06035523</url>
    </required_header>
    <id_info>
      <org_study_id>AROA 002</org_study_id>
      <nct_id>NCT06035523</nct_id>
    </id_info>
    <brief_title>Clinical Study Evaluating Wound Closure With Endoform™ and Symphony™</brief_title>
    <official_title>A Single Arm Pilot Study Evaluating Wound Closure With a Unique Staged Application of Endoform™ and Symphony™ in the Treatment of Non-Healing Diabetic Foot Ulcers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aroa Biosurgery Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Professional Education and Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Aroa Biosurgery Limited</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Study will evaluate the performance and safety of Endoform™ Natural and Endoform™&#xD;
        Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic&#xD;
        foot ulcers after 12 weeks of treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        About 50 subjects will take part in this study. The purpose of this study is to evaluate the&#xD;
        performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with&#xD;
        Symphony™ (together, the 'Products') in the treatment of acute or chronic non-healing wounds,&#xD;
        including diabetic foot ulcers Wagner Grade 1 or 2, after 12 weeks of treatment.&#xD;
  &#xD;
        Following initial enrollment, eligible subjects will then undergo&#xD;
  &#xD;
          -  a treatment phase involving weekly treatment and evaluations for up to 12 weeks,&#xD;
  &#xD;
          -  subjects that heal will enter a follow-up period that includes 1 visit (Healing&#xD;
             Confirmation Visit), 2 weeks from initial healing.&#xD;
  &#xD;
          -  If the subject does not heal, they will exit at Week 13, End of Study visit.&#xD;
  &#xD;
        All subjects will require accepted routine procedures as part of standard of care (SOC):&#xD;
        offloading of the DFU (removeable cast boot or total contact casting [TCC] if the subject's&#xD;
        foot is too large for a removeable cast boot), appropriate sharp debridement, and infection&#xD;
        management. In addition, each subject will receive a wound care covering comprising of either&#xD;
        Endoform™ Antimicrobial, Endoform™ Natural or Symphony™ followed by a silicone non-adherent&#xD;
        dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4x4 gauze pads,&#xD;
        soft roll, compressive wrap and Coban (Threeflex 3-layer or equivalent).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 29, 2021</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to heal within 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Time to heal of index ulcer defined as 100% re-epithelialization within 12 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage area reduction at 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Area reduction percentage of ulcers at 12 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in wound quality of life (per W-QoL)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes in wound quality of life (W-QoL), using the W-QoL short questionnaire administered on Study Visit 1 (as a baseline) and after 12 weeks of treatment (End of Study Visit). Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in subjects reported pain levels (NPRS)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Change in subject-reported pain levels using the 0-10 Numeric Pain Rating Scale at baseline (Study Visit 1) and after 12 weeks of treatment EOS visit (End of Study Visit).On the numerical pain scale, the number 0 represents &quot;no pain&quot; and the number 10 represents &quot;the worst possible pain&quot;.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Product wastage</measure>
      <time_frame>12 weeks</time_frame>
      <description>For each product, the size actually used will be the basis to calculate the area of the product.&#xD;
  Based on the investigator's notes, wound area at time of application will be calculated as a rectangle (length x width) reduced to an ellipsoid.&#xD;
  Wastage = ((area of product - area of wound)/area of product)*100</description>
    </other_outcome>
    <other_outcome>
      <measure>Cost to closure</measure>
      <time_frame>12 weeks</time_frame>
      <description>Calculation of cost of treatment, including number of device applications for each treatment group</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Wound Healing</condition>
    <condition>Diabetic Foot</condition>
    <condition>Chronic Foot Ulcer</condition>
    <condition>Foot Ulcer</condition>
    <arm_group>
      <arm_group_label>Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Arm receives application of Endoform™ Antibacterial, Endoform™ Natural and Symphony™ and appropriate Off - loading</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Endoform™ Antibacterial</intervention_name>
      <description>Application of Endoform™ Antibacterial</description>
      <arm_group_label>Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Endoform™ Natural</intervention_name>
      <description>Application of Endoform™ Natural</description>
      <arm_group_label>Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Symphony™</intervention_name>
      <description>Application of Symphony™</description>
      <arm_group_label>Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. At least 18 years old, inclusive.&#xD;
  &#xD;
            -  2. Presence of a DFU, Wagner Grade 1 or 2 (see Appendix D for definitions), extending&#xD;
               through the dermis provided it is below the medial aspect of the malleolus.&#xD;
  &#xD;
            -  3. The index ulcer (ulcer to be evaluated in the study) will be the largest ulcer if&#xD;
               two or more DFUs are present with the same Wagner grade and will be the only one&#xD;
               evaluated in the study. If other ulcerations are present on the same foot, they must&#xD;
               be more than 2 cm distant from the index ulcer.&#xD;
  &#xD;
            -  4. Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1&#xD;
               year, as of the date the subject consents for study.&#xD;
  &#xD;
            -  5. Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.&#xD;
  &#xD;
            -  6. Within 3 months of SV1, adequate circulation to the affected foot as documented by&#xD;
               a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP)&#xD;
               measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 using&#xD;
               the affected study extremity. As an alternative, arterial Doppler ultrasound can be&#xD;
               performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the&#xD;
               level of the ankle or a TBI (Toe Brachial Index) of &gt; 0.6 is acceptable.&#xD;
  &#xD;
            -  7. The target ulcer has been offloaded for at least 14 days, prior to SV1.&#xD;
  &#xD;
            -  8. 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;
            -  9. Subject understands and is willing to participate in the clinical study and can&#xD;
               comply with weekly visits.&#xD;
  &#xD;
            -  10. Subjects must have read and signed the IRB approved ICF before screening&#xD;
               procedures are performed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other&#xD;
               than diabetes.&#xD;
  &#xD;
            -  2. Index ulcer, in the opinion of the investigator, is suspicious for cancer and&#xD;
               should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.&#xD;
  &#xD;
            -  3. Index ulcer is overtly infected (i.e., purulent drainage).&#xD;
  &#xD;
            -  4. Subjects with a history of more than two weeks of treatment with&#xD;
               immune-suppressants (including systemic corticosteroids &gt;10mg daily dose), cytotoxic&#xD;
               chemotherapy, or application of topical steroids to the ulcer surface within 1-month&#xD;
               prior to first SV1, or who receive such medications during the screening period or who&#xD;
               are anticipated to require such medications during the course of the study.&#xD;
  &#xD;
            -  5. Subjects on any investigational drug(s) or therapeutic device(s) within 30 days&#xD;
               preceding SV1.&#xD;
  &#xD;
            -  6. History of radiation at the ulcer site (regardless of time since last radiation&#xD;
               treatment).&#xD;
  &#xD;
            -  7. Index ulcer has been previously treated or will need to be treated with any&#xD;
               prohibited therapies.&#xD;
  &#xD;
            -  8. Subjects with a previous diagnosis of HIV or Hepatitis C.&#xD;
  &#xD;
            -  9. Presence of any condition(s) which seriously compromises the subject's ability to&#xD;
               complete this study or has a known history of poor adherence with medical treatment.&#xD;
  &#xD;
            -  10. Osteomyelitis or bone infection of the affected foot as verified by xray within 30&#xD;
               days prior to the first screening visit. (In the event of an ambiguous diagnosis, the&#xD;
               Principal Investigator will make the final decision).&#xD;
  &#xD;
            -  11. Subject is pregnant or breast-feeding.&#xD;
  &#xD;
            -  12. Presence of diabetes with poor metabolic control as documented with an HbA1c &gt;12.0&#xD;
               within last 90 days.&#xD;
  &#xD;
            -  13. Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0&#xD;
               mg/dL within 6 months of enrollment&#xD;
  &#xD;
            -  14. Presence of acute Charcot Neuroarthropathy to the affected limb&#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>David Armstrong, DPM, MD PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Keck School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shelby Caylor</last_name>
      <phone>513-815-8160</phone>
      <email>scaylor@periedu.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Frances Parker, DMP</last_name>
      <phone>540-581-6915</phone>
      <email>fparker@peredu.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>South Florida Lower Extremity Center</name>
        <address>
          <city>Hollywood</city>
          <state>Florida</state>
          <zip>33312</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Karla Taylor</last_name>
        <phone>954-278-3890</phone>
        <phone_ext>3</phone_ext>
        <email>ksteph8624@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Nooshin Zolfaghari, DPM</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Foot and Ankle Specialists of the Mid-Atlantic</name>
        <address>
          <city>Salem</city>
          <state>Virginia</state>
          <zip>24153</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kristie Guilliams</last_name>
        <phone>540-395-3107</phone>
        <email>kguilliams@footandankle-usa.com</email>
      </contact>
      <investigator>
        <last_name>Ivan Rubiano, DPM</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Extracellular matrix</keyword>
    <keyword>Regenerative medicine</keyword>
    <keyword>Leg ulcer</keyword>
    <keyword>Diabetes complications</keyword>
    <keyword>Diabetic Angiopathies</keyword>
    <keyword>Diabetes Mellitus</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>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anti-Bacterial Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06035523
  org study id: AROA 002
  nct id: NCT06035523
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  Study will evaluate the performance and safety of Endoform™ Natural and Endoform™
        Antimicrobial in conjunction with Symphony™ in the treatment of chronic non-healing diabetic
        foot ulcers after 12 weeks of treatment.
  About 50 subjects will take part in this study. The purpose of this study is to evaluate the
        performance and safety of Endoform™ Natural and Endoform™ Antimicrobial in conjunction with
        Symphony™ (together, the 'Products') in the treatment of acute or chronic non-healing wounds,
        including diabetic foot ulcers Wagner Grade 1 or 2, after 12 weeks of treatment.
  
        Following initial enrollment, eligible subjects will then undergo
  
          -  a treatment phase involving weekly treatment and evaluations for up to 12 weeks,
  
          -  subjects that heal will enter a follow-up period that includes 1 visit (Healing
             Confirmation Visit), 2 weeks from initial healing.
  
          -  If the subject does not heal, they will exit at Week 13, End of Study visit.
  
        All subjects will require accepted routine procedures as part of standard of care (SOC):
        offloading of the DFU (removeable cast boot or total contact casting [TCC] if the subject's
        foot is too large for a removeable cast boot), appropriate sharp debridement, and infection
        management. In addition, each subject will receive a wound care covering comprising of either
        Endoform™ Antimicrobial, Endoform™ Natural or Symphony™ followed by a silicone non-adherent
        dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4x4 gauze pads,
        soft roll, compressive wrap and Coban (Threeflex 3-layer or equivalent).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks
  time frame: 12 weeks
  description: Percentage of index ulcer defined as 100% re-epithelialization within 12 weeks
  measure: Time to heal within 12 weeks
  time frame: 12 weeks
  description: Time to heal of index ulcer defined as 100% re-epithelialization within 12 weeks
  measure: Percentage area reduction at 12 weeks
  time frame: 12 weeks
  description: Area reduction percentage of ulcers at 12 weeks
  measure: Changes in wound quality of life (per W-QoL)
  time frame: 12 weeks
  description: Changes in wound quality of life (W-QoL), using the W-QoL short questionnaire administered on Study Visit 1 (as a baseline) and after 12 weeks of treatment (End of Study Visit). Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).
  measure: Change in subjects reported pain levels (NPRS)
  time frame: 12 weeks
  description: Change in subject-reported pain levels using the 0-10 Numeric Pain Rating Scale at baseline (Study Visit 1) and after 12 weeks of treatment EOS visit (End of Study Visit).On the numerical pain scale, the number 0 represents "no pain" and the number 10 represents "the worst possible pain".
  measure: Product wastage
  time frame: 12 weeks
  description: For each product, the size actually used will be the basis to calculate the area of the product.
  Based on the investigator's notes, wound area at time of application will be calculated as a rectangle (length x width) reduced to an ellipsoid.
  Wastage = ((area of product - area of wound)/area of product)*100
  measure: Cost to closure
  time frame: 12 weeks
  description: Calculation of cost of treatment, including number of device applications for each treatment group
  arm group label: Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer
  arm group type: Other
  description: Arm receives application of Endoform™ Antibacterial, Endoform™ Natural and Symphony™ and appropriate Off - loading
  intervention type: Device
  intervention name: Endoform™ Antibacterial
  description: Application of Endoform™ Antibacterial
  arm group label: Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer
  intervention type: Device
  intervention name: Endoform™ Natural
  description: Application of Endoform™ Natural
  arm group label: Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer
  intervention type: Device
  intervention name: Symphony™
  description: Application of Symphony™
  arm group label: Subjects with a Wagner Grade 1 or 2 diabetic foot ulcer
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: David Armstrong, DPM, MD PhD
  role: Study Chair
  affiliation: Keck School of Medicine
  last name: Shelby Caylor
  phone: 513-815-8160
  email: scaylor@periedu.com
  last name: Frances Parker, DMP
  phone: 540-581-6915
  email: fparker@peredu.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  mesh term: Ulcer
  mesh term: Wounds and Injuries
  mesh term: Anti-Bacterial Agents
  sharing ipd: No