<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/NCT03796793</url>
  </required_header>
  <id_info>
    <org_study_id>20180256</org_study_id>
    <secondary_id>R01AR073614</secondary_id>
    <nct_id>NCT03796793</nct_id>
  </id_info>
  <brief_title>Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers</brief_title>
  <official_title>Developing Strategies for Effective Debridement in Patients for Venous Leg Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to use genomic profiling, candidate genes and proteins to develop&#xD;
      guided surgical debridement to improve healing in chronic non-healing venous leg ulcers&#xD;
      (VLUs) and to test the efficacy of this approach.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the genetic profile after debridement in the intervention group.</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>RNA sequencing will be used to determine the number of differentially expressed genes of the intervention group in samples collected pre-debridement to samples collected post-debridement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent rate of healing</measure>
    <time_frame>Up to 4 weeks</time_frame>
    <description>Percent rate of healing is measured at every weekly visit and divided by 4 to calculate the average percent wound healing rate in cm2/week.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Venous Leg Ulcer</condition>
  <arm_group>
    <arm_group_label>Wound Edge Debridement Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this group will receive only the standard care of treatment for up to 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Wound Edge Debridement</intervention_name>
    <description>Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.</description>
    <arm_group_label>Wound Edge Debridement Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care Treatment</intervention_name>
    <description>Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.</description>
    <arm_group_label>Standard care group</arm_group_label>
    <arm_group_label>Wound Edge Debridement Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt;18 years of age&#xD;
&#xD;
          2. Conformation of venous disease by non-invasive venous studies with either&#xD;
             Doppler-confirmed venous reflux, or having ≥ 2 clinical characteristics of venous&#xD;
             insufficiency (varicose veins, lipodermatosclersosis, venous dermatitis, atrophie&#xD;
             blanche, edema)&#xD;
&#xD;
          3. have a venous ulcer between the knee and ankle, at or above the malleolus&#xD;
&#xD;
          4. wound size would be greater than or equal to 5cm2 in area without exposed tendon,&#xD;
             muscle or bone&#xD;
&#xD;
          5. wound duration of at least 6 months&#xD;
&#xD;
          6. VLU containing yellow/white slough with or without fibrous/scar tissue and/or&#xD;
             non-viable tissue&#xD;
&#xD;
          7. ability of subject to tolerate limb compression bandage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. history of diabetes mellitus and a HbA1c &gt; 12% (obtained within past 6 months)&#xD;
&#xD;
          2. Ankle brachial index(ABI) less than 0.80&#xD;
&#xD;
          3. any active cancer other than a nonmelanoma skin cancer; any previous cancer must be in&#xD;
             remission for at least 5 years&#xD;
&#xD;
          4. suspicion of malignancy within VLU&#xD;
&#xD;
          5. life expectancy &lt;6 months&#xD;
&#xD;
          6. history of kidney disease and creatinine greater than 2.0 (obtained within past 6&#xD;
             months)&#xD;
&#xD;
          7. history of liver disease and liver function test (ALT, AST, ALK PHOS, and bilirubin)&#xD;
             &gt;2x upper limit of normal (obtained within past 6 months)&#xD;
&#xD;
          8. requirement for long-term systemic corticosteroids or immunosuppressive therapy, or&#xD;
             history of corticosteroid or immunosuppressive use in the 4 weeks prior to study entry&#xD;
&#xD;
          9. history of immunodeficiency&#xD;
&#xD;
         10. ulcers due to none venous etiology and leg ulcers associated with mixed etiology&#xD;
&#xD;
         11. Untreated osteomyelitis&#xD;
&#xD;
         12. Hepatitis&#xD;
&#xD;
         13. acute deep venous thrombosis&#xD;
&#xD;
         14. allergy to lidocaine and/or epinephrine&#xD;
&#xD;
         15. Subject's inability to successfully tolerate compression therapy that is changed&#xD;
             weekly&#xD;
&#xD;
         16. Skin ulcer previously treated within the last 4 weeks with biologic therapies (e.g.&#xD;
             cell therapy or growth factors)&#xD;
&#xD;
         17. if currently incarcerated&#xD;
&#xD;
         18. known pregnancy&#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>Marjana Tomic-Canic, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Kirsner, MD/PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aliette Espinosa</last_name>
    <phone>305-689-3376</phone>
    <email>a.espinosa2@med.miami.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aliette Espinosa</last_name>
      <phone>305-689-3376</phone>
      <email>a.espinosa2@med.miami.edu</email>
    </contact>
    <investigator>
      <last_name>Marjana Tomic-Canic, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Robert S. Kirsner</investigator_full_name>
    <investigator_title>Professor &amp; Chairman</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicose Ulcer</mesh_term>
    <mesh_term>Leg 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/NCT03796793
org study id: 20180256
secondary id: R01AR073614
nct id: NCT03796793
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this project is to use genomic profiling, candidate genes and proteins to develop
      guided surgical debridement to improve healing in chronic non-healing venous leg ulcers
      (VLUs) and to test the efficacy of this approach.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in the genetic profile after debridement in the intervention group.
time frame: Baseline and 4 weeks
description: RNA sequencing will be used to determine the number of differentially expressed genes of the intervention group in samples collected pre-debridement to samples collected post-debridement.
measure: Percent rate of healing
time frame: Up to 4 weeks
description: Percent rate of healing is measured at every weekly visit and divided by 4 to calculate the average percent wound healing rate in cm2/week.
arm group label: Wound Edge Debridement Group
arm group type: Experimental
description: Participants in this group will receive wound edge debridement in addition to standard of care (SOC) treatment for up to 4 weeks.
arm group label: Standard care group
arm group type: Active Comparator
description: Participants in this group will receive only the standard care of treatment for up to 4 weeks.
intervention type: Procedure
intervention name: Wound Edge Debridement
description: Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.
arm group label: Wound Edge Debridement Group
intervention type: Other
intervention name: Standard of Care Treatment
description: Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
arm group label: Standard care group
arm group label: Wound Edge Debridement Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marjana Tomic-Canic, PhD
role: Principal Investigator
affiliation: University of Miami
last name: Robert Kirsner, MD/PhD
role: Principal Investigator
affiliation: University of Miami
last name: Aliette Espinosa
phone: 305-689-3376
email: a.espinosa2@med.miami.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Robert S. Kirsner
investigator title: Professor & Chairman
mesh term: Varicose Ulcer
mesh term: Leg Ulcer
mesh term: Ulcer
sharing ipd: No