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/NCT06035536</url>
    </required_header>
    <id_info>
      <org_study_id>AROA 003</org_study_id>
      <nct_id>NCT06035536</nct_id>
    </id_info>
    <brief_title>Clinical Study Evaluating Symphony™ Versus Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers</brief_title>
    <official_title>A Multi-Center, Randomized Controlled Clinical Investigation Evaluating Wound Closure With Symphony™ Versus Standard of Care 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>
        The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC)&#xD;
        in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of&#xD;
        treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        About 120 subjects will take part in this study. Subjects with a Wagner Grade 1 or 2 Diabetic&#xD;
        Foot Ulcers will be randomized at a ratio of 1:1 to one of the two treatment groups at the&#xD;
        time of completion of screening to either Symphony™ treatment or Standard of Care (SOC)&#xD;
        treatment groups.&#xD;
  &#xD;
        Following initial enrolment, eligible subjects will then undergo:&#xD;
  &#xD;
          -  A screening phase consisting of 14 days to determine eligibility.&#xD;
  &#xD;
          -  Eligible subjects will then undergo a treatment phase involving weekly treatment and&#xD;
             evaluations for up to 12 weeks.&#xD;
  &#xD;
          -  Subjects that heal will undergo a follow-up phase 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;
        Both treatment groups will receive accepted routine procedures being part of SOC, including&#xD;
        offloading of the DFU (removable cast boot or total contact casting [TCC] if the subject's&#xD;
        foot is too large for a removable cast boot), appropriate sharp or surgical debridement, and&#xD;
        infection management.&#xD;
  &#xD;
        In addition to what is noted above, Group 1 will receive a weekly application of Symphony™&#xD;
        and Group 2 will receive SOC comprising of calcium alginate Fibracol dressing. Both Groups&#xD;
        will have a silicone non-adherent dressing (MepitelTM or equivalent), a padded 3-layer&#xD;
        dressing comprised of 4x4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3layer&#xD;
        or equivalent) applied.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 8, 2023</start_date>
    <completion_date type="Anticipated">December 27, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 27, 2024</primary_completion_date>
    <phase>N/A</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>
      <masking_description>None (Open Label)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of index ulcers 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 ulcer at 12 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in wound quality of life (per W-QoL)</measure>
      <time_frame>after 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) normalized to a single value. 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 pain levels during the clinical investigation</measure>
      <time_frame>12 weeks</time_frame>
      <description>Change in subject-reported pain levels using the 0-10 Numeric Pain Rating Scale at each weekly 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 (Symphony only)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Product wastage (applies only to DFUs treated with Symphony). Area of Symphony device; wound area at time of application based on digital planimetry imaging of area. Percentage wastage: (Area of DFU - area of Symphony/area of DFU) x 100.</description>
    </other_outcome>
    <other_outcome>
      <measure>Cost to closure (both treatment groups; all wounds, and only closed wounds)</measure>
      <time_frame>12 weeks</time_frame>
      <description>Costs for all wounds per treatment group, and cost of healed wounds only per treatment group. Final values are cost per wound.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Diabetic Foot</condition>
    <condition>Diabetic Foot Ulcer</condition>
    <condition>Foot Ulcer</condition>
    <condition>Chronic Foot Ulcer</condition>
    <arm_group>
      <arm_group_label>Symphony™ treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Arm receives an application of Symphony™ treatment and appropriate Off-loading.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care (SOC) treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Arm receives an application of SOC comprising of calcium alginate Fibracol dressing and appropriate Off-loading.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Symphony™ plus Off-loading</intervention_name>
      <description>Application of Symphony™</description>
      <arm_group_label>Symphony™ treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Wound Dressing comprising of calcium alginate Fibracol</intervention_name>
      <description>Application of Wound Dressing comprising of calcium alginate Fibracol.</description>
      <arm_group_label>Standard of Care (SOC) treatment</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 B 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 TV1.&#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;
  &#xD;
            -  15. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1&#xD;
               to the TV1/Randomization visit&#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</last_name>
      <phone>540-581-6915</phone>
      <email>fparker@peredu.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>LA Foot and Ankle</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90010</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maira Jackson</last_name>
        <phone>213-365-0793</phone>
        <email>maira@lafootpain.com</email>
      </contact>
      <investigator>
        <last_name>Felix Sigal, DPM</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Bay Area Foot Care</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94115</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maria Peralta</last_name>
        <phone>800-363-1069</phone>
        <phone_ext>104</phone_ext>
        <email>maria@ccr-trials.com</email>
      </contact>
      <investigator>
        <last_name>Alex Reyzelman, DPM</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Doctor's Research Network</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33143</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Patria Division</last_name>
        <phone>305-665-3017</phone>
        <email>pdivison@drnmiami.com</email>
      </contact>
      <investigator>
        <last_name>Jason Hanft</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Barry University Clinical Research</name>
        <address>
          <city>Tamarac</city>
          <state>Florida</state>
          <zip>33321</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maria Swartz</last_name>
        <phone>305-836-7550</phone>
        <email>MSwartz@barry.edu</email>
      </contact>
      <investigator>
        <last_name>Robert Snyder, DPM</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Foot and Ankle Specialists of the Mid-Atlantic</name>
        <address>
          <city>Gastonia</city>
          <state>North Carolina</state>
          <zip>28054</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dana Jones</last_name>
        <phone>704-861-0425</phone>
        <email>dvandyck@footandankle-usa.com</email>
      </contact>
      <investigator>
        <last_name>Ryan Meredith, DPM</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Lower Extremity Institute for Research and Therapy</name>
        <address>
          <city>Boardman</city>
          <state>Ohio</state>
          <zip>44512</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jessica DiDomenico</last_name>
        <phone>234-719-7588</phone>
        <email>jessica@leirt.com</email>
      </contact>
      <investigator>
        <last_name>Lawrence A DiDomenico, DPM</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 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 Mellitus</keyword>
    <keyword>Diabetic Angiopathies</keyword>
    <keyword>Diabetes Complications</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Calcium</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/NCT06035536
  org study id: AROA 003
  nct id: NCT06035536
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The study will evaluate the safety and performance of Symphony™ versus Standard of Care (SOC)
        in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of
        treatment.
  About 120 subjects will take part in this study. Subjects with a Wagner Grade 1 or 2 Diabetic
        Foot Ulcers will be randomized at a ratio of 1:1 to one of the two treatment groups at the
        time of completion of screening to either Symphony™ treatment or Standard of Care (SOC)
        treatment groups.
  
        Following initial enrolment, eligible subjects will then undergo:
  
          -  A screening phase consisting of 14 days to determine eligibility.
  
          -  Eligible subjects will then undergo a treatment phase involving weekly treatment and
             evaluations for up to 12 weeks.
  
          -  Subjects that heal will undergo a follow-up phase 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.
  
        Both treatment groups will receive accepted routine procedures being part of SOC, including
        offloading of the DFU (removable cast boot or total contact casting [TCC] if the subject's
        foot is too large for a removable cast boot), appropriate sharp or surgical debridement, and
        infection management.
  
        In addition to what is noted above, Group 1 will receive a weekly application of Symphony™
        and Group 2 will receive SOC comprising of calcium alginate Fibracol dressing. Both Groups
        will have 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 3layer
        or equivalent) applied.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: None (Open Label)
  measure: Percentage of index ulcers 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 ulcer at 12 weeks
  measure: Changes in wound quality of life (per W-QoL)
  time frame: after 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) normalized to a single value. Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (very much).
  measure: Change in pain levels during the clinical investigation
  time frame: 12 weeks
  description: Change in subject-reported pain levels using the 0-10 Numeric Pain Rating Scale at each weekly visit. On the numerical pain scale, the number 0 represents "no pain" and the number 10 represents "the worst possible pain".
  measure: Product wastage (Symphony only)
  time frame: 12 weeks
  description: Product wastage (applies only to DFUs treated with Symphony). Area of Symphony device; wound area at time of application based on digital planimetry imaging of area. Percentage wastage: (Area of DFU - area of Symphony/area of DFU) x 100.
  measure: Cost to closure (both treatment groups; all wounds, and only closed wounds)
  time frame: 12 weeks
  description: Costs for all wounds per treatment group, and cost of healed wounds only per treatment group. Final values are cost per wound.
  arm group label: Symphony™ treatment
  arm group type: Experimental
  description: Arm receives an application of Symphony™ treatment and appropriate Off-loading.
  arm group label: Standard of Care (SOC) treatment
  arm group type: Active Comparator
  description: Arm receives an application of SOC comprising of calcium alginate Fibracol dressing and appropriate Off-loading.
  intervention type: Device
  intervention name: Symphony™ plus Off-loading
  description: Application of Symphony™
  arm group label: Symphony™ treatment
  intervention type: Device
  intervention name: Wound Dressing comprising of calcium alginate Fibracol
  description: Application of Wound Dressing comprising of calcium alginate Fibracol.
  arm group label: Standard of Care (SOC) treatment
  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
  phone: 540-581-6915
  email: fparker@peredu.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  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: Calcium
  sharing ipd: No