<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/NCT04457752</url>
  </required_header>
  <id_info>
    <org_study_id>HITIDE</org_study_id>
    <nct_id>NCT04457752</nct_id>
  </id_info>
  <brief_title>Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®)</brief_title>
  <official_title>A Randomised Controlled Multicentre Clinical Trial, Evaluating the Efficacy of Dual Layer Amniotic Membrane (Artacent®) and Standard of Care Versus Standard of Care Alone in the Healing of Chronic Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SerenaGroup, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tides Medical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>SerenaGroup, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of Dual Layer&#xD;
      Amniotic Membrane (Artacent®) and Standard of Care versus Standard of Care alone in the&#xD;
      healing Chronic Diabetic Foot Ulcers. Multi-center, open label, randomized controlled trial.&#xD;
      Study is estimated to require 12 months from first subject enrolled to last subject visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetic foot ulcers (DFUs) challenge the most experienced wound care specialist. The US&#xD;
      Wound Registry reports that only 40% of DFUs heal in 12 weeks1. Woundologists have adopted&#xD;
      the phrase, &quot;time is tissue.&quot; This adage reminds clinicians that the longer a DFU remains&#xD;
      open, the greater the risk of infection, major amputation and death. The diabetic with a foot&#xD;
      ulcer has a mortality rate of 47% which exceeds the mortality2 from most common cancers3.&#xD;
      Beyond patient suffering, the treatment of DFUs cost the US health care system more than 15&#xD;
      billion dollars annually4.&#xD;
&#xD;
      In recent years, several clinical trials have demonstrated that products derived from human&#xD;
      placental membranes promote the healing of DFUs5. Research has confirmed that growth factors&#xD;
      present in amniotic membrane induce angiogenesis, stimulate human dermal fibroblast&#xD;
      proliferation, and recruit stem cells important to wound repair and regeneration to the DFU6.&#xD;
      All these factors are highly desirable properties in the healing of chronic DFUs.&#xD;
&#xD;
      A novel dual layer amniotic membrane (DLAM, Artacent™, Tides Medical. Lafayette, LA)&#xD;
      potentially can increase the delivery of growth factors due to its double layer of amniotic&#xD;
      membrane. A prospective case series demonstrated good healing rates in DFUs: 65% healing at&#xD;
      12 weeks7. The current study is the first randomized clinical trial evaluating the efficacy&#xD;
      of DLAM in DFUs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2023</completion_date>
  <primary_completion_date type="Actual">March 1, 2022</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>
    <intervention_model_description>Dual Layer Amniotic Membrane (DLAM). Artacent® Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized.&#xD;
Atracent®, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Wound Closure</measure>
    <time_frame>1-12 weeks</time_frame>
    <description>- The percentage of target ulcers achieving complete wound closure in 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage Wound Area Reduction</measure>
    <time_frame>1-12 weeks</time_frame>
    <description>- Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry and physical examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1-12 weeks</time_frame>
    <description>The number of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time wearing offloading boot</measure>
    <time_frame>1-12 Weeks</time_frame>
    <description>- Compliance with a prescribed offloading boot measured as % of time wearing the boot</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scale (The Pain, Enjoyment of Life and General Activity Scale). 0 = no pain , 10 = pain as bad as you can imagine</measure>
    <time_frame>TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit</time_frame>
    <description>- Change in pain in the target ulcer assessed using the PEG scale. [Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in bacterial Load</measure>
    <time_frame>1-12 Weeks</time_frame>
    <description>- Exploratory Endpoint: changes in bacterial load measured using fluorescence imaging</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Chronic Diabetic Foot Ulcers</condition>
  <arm_group>
    <arm_group_label>Dual Layer Amniotic Membrane (DLAM) + SOC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DLAM (Up to 10 weekly DLAM applications) + Standard of Care (sharp debridement, offloading, and proper moisture balance).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of Care: sharp debridement, offloading, and proper moisture balance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Dual Layer Amniotic Membrane (DLAM). Artacent®</intervention_name>
    <description>Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized.&#xD;
Atracent®, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers.</description>
    <arm_group_label>Dual Layer Amniotic Membrane (DLAM) + SOC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects must be at least 18 years of age or older,&#xD;
&#xD;
          2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.&#xD;
&#xD;
          3. At randomization subjects must have a target ulcer with a minimum surface area of 0.7&#xD;
             cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the Tissue&#xD;
             Analytics photographic planimetry App.&#xD;
&#xD;
          4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52&#xD;
             weeks of standard of care prior to the initial screening visit.&#xD;
&#xD;
          5. The target ulcer must be located on the foot with at least 50% of the ulcer below the&#xD;
             malleolus.&#xD;
&#xD;
          6. The target ulcer must be full thickness without exposed bone.&#xD;
&#xD;
          7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any&#xD;
             of the following methods performed within 3 months of the first screening visit are&#xD;
             acceptable:&#xD;
&#xD;
               1. ABI between 0.7 and ≤ 1.3;&#xD;
&#xD;
               2. TBI ≥ 0.6;&#xD;
&#xD;
               3. TCOM ≥ 40 mmHg;&#xD;
&#xD;
               4. PVR: biphasic.&#xD;
&#xD;
          8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The&#xD;
             largest ulcer satisfying the inclusion and exclusion criteria will be designated as&#xD;
             the target ulcer.&#xD;
&#xD;
          9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least&#xD;
             30 days prior to randomization.&#xD;
&#xD;
         10. The subject must consent to using the prescribed off-loading method for the duration&#xD;
             of the study.&#xD;
&#xD;
         11. The subject must agree to attend the weekly study visits required by the protocol.&#xD;
&#xD;
         12. The subject must be willing and able to participate in the informed consent process.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A subject known to have a life expectancy of &lt; 6 months is excluded.&#xD;
&#xD;
          2. The subject is excluded if the target ulcer is not secondary to diabetes.&#xD;
&#xD;
          3. If the target ulcer is infected or if there is cellulitis in the surrounding skin, the&#xD;
             subject is excluded.&#xD;
&#xD;
          4. If there is evidence of osteomyelitis complicating the target ulcer, the subject is&#xD;
             excluded.&#xD;
&#xD;
          5. A potential subject cannot have an infection in the target ulcer or in a remote&#xD;
             location that requires systemic antibiotic therapy.&#xD;
&#xD;
          6. A subject receiving immunosuppressants (including systemic corticosteroids at doses&#xD;
             greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is&#xD;
             excluded.&#xD;
&#xD;
          7. The topical application of steroids to the ulcer surface within one month of initial&#xD;
             screening is not permitted.&#xD;
&#xD;
          8. A subject with a previous partial amputation on the affected foot is excluded if the&#xD;
             resulting deformity impedes proper offloading of the target ulcer.&#xD;
&#xD;
          9. If a subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3&#xD;
             months of the initial screening visit he/she is excluded.&#xD;
&#xD;
         10. The subject is excluded if the surface area measurement of the Target ulcer decreases&#xD;
             by 40% or more during the 4-week screening phase: the 4 weeks from the initial&#xD;
             screening visit (SV1) to the TV-1/randomization visit during which time the subject&#xD;
             received SOC.&#xD;
&#xD;
         11. A Subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper&#xD;
             offloading of the target ulcer is excluded.&#xD;
&#xD;
         12. Women who are pregnant or considering becoming pregnant within the next 6 months are&#xD;
             excluded.&#xD;
&#xD;
         13. A potential subject with end stage renal disease requiring dialysis is excluded.&#xD;
&#xD;
         14. A subject who participated in a clinical trial involving treatment with an&#xD;
             investigational product within the previous 30 days is excluded.&#xD;
&#xD;
         15. A subject who in the opinion of the investigator, has a medical or psychological&#xD;
             condition that may interfere with study assessments is excluded.&#xD;
&#xD;
         16. A Subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product&#xD;
             (CTP) in the 30 days prior to the initial screening visit is excluded.&#xD;
&#xD;
         17. A Subject is excluded if the MolecuLight Device shows a positive fluorescence image in&#xD;
             the wound bed on TV1&#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>Thomas E Serena, MD,FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Serena Group, Inc</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas E Serena, MD,FACS</last_name>
    <phone>814-688-4000</phone>
    <email>serena@serenagroups.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Doug Payne</last_name>
    <phone>888-494-4441</phone>
    <email>dpayne@tidesmedical.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Titan Research</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kwadjo Walker</last_name>
      <email>kwalker@viableresearch.org</email>
    </contact>
    <contact_backup>
      <last_name>Noreen Rana</last_name>
      <email>nrana.alas@viableresearch.org</email>
    </contact_backup>
    <investigator>
      <last_name>Yadwinder Dhillon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New Hope Podiatry</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90063</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francis Morfin</last_name>
      <email>francis_morfin@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Demitric Lopez</last_name>
      <email>demitriclopez@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Charles E Ananian, DPM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Research</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yalily Perez</last_name>
      <email>yalilyp@royalresearchcorp.com</email>
    </contact>
    <contact_backup>
      <last_name>Yaili Perez</last_name>
      <email>yailip@royalresearchcorp.com</email>
    </contact_backup>
    <investigator>
      <last_name>Melissa Perlman, DPM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pharma Research Associates</name>
      <address>
        <city>Westchester</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Regional Infectious Disease and Infusion Center, Inc</name>
      <address>
        <city>LaGrange</city>
        <state>Georgia</state>
        <zip>30240</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bhuvan Doneepudi, MS</last_name>
      <email>bhuvan@nobadbugs.com</email>
    </contact>
    <investigator>
      <last_name>Ravi Kamepalli@nobadbugs.com</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hoosier Foot and Ankle</name>
      <address>
        <city>Fishers</city>
        <state>Indiana</state>
        <zip>46037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheri Britt</last_name>
      <email>cheribhfa@outlook.com</email>
    </contact>
    <contact_backup>
      <last_name>James Vestile, DPM</last_name>
      <email>jvestile@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>James Vestile, DPM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Serena Group Baton Rouge</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas E Serena, MS, FACS</last_name>
      <email>serena@serenagroups.com</email>
    </contact>
    <contact_backup>
      <last_name>Khristina Serena</last_name>
      <email>kserena@serenagroups.com</email>
    </contact_backup>
    <investigator>
      <last_name>Thomas Serena, MD,FACS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Opelousas Medical Research Consultants, LLC</name>
      <address>
        <city>Opelousas</city>
        <state>Louisiana</state>
        <zip>70570</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kerry Thibodeaux, MD</last_name>
      <email>KerryThibodeaux1960@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Marcus Speyrer</last_name>
      <email>mspeyrer@thewoundtreatmentcenter.com</email>
    </contact_backup>
    <investigator>
      <last_name>Kerry Thibodeaux, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Sinai St. Luke's Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10025</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denise Alabi</last_name>
      <email>Denise.Alabi@mountsinai.org</email>
    </contact>
    <investigator>
      <last_name>John Lantis, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Foot and Ankle Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Windy Cole, DPM</last_name>
      <email>drwec@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Stacey Coe</last_name>
      <email>scoe3@kent.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Windy Cole, DPM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Heal Foundation</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74146</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lam Le, MD</last_name>
      <email>lam.le@sjmc.org</email>
    </contact>
    <contact_backup>
      <last_name>Phil Salon</last_name>
      <email>philbert.salon@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Lam Le, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Foot and Ankle Wellness Center of Western Pennsylvania</name>
      <address>
        <city>Ford City</city>
        <state>Pennsylvania</state>
        <zip>16226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Schrecengost</last_name>
      <phone>724-664-3843</phone>
      <email>nschrecengost@serenagroups.com</email>
    </contact>
    <investigator>
      <last_name>Matthew Sabo, DPM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Armstrong County Memorial Hospital - Wound Clinic</name>
      <address>
        <city>Kittanning</city>
        <state>Pennsylvania</state>
        <zip>16201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bryan Doner, DO</last_name>
      <email>DrDoner@dandpmedicalgroup.com</email>
    </contact>
    <contact_backup>
      <last_name>Nicole Schrecengost, LPN</last_name>
      <email>nschrecengost@serenagroups.com</email>
    </contact_backup>
    <investigator>
      <last_name>Bryan Doner, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Martin Foot and Ankle</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17402</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Beth Mincer</last_name>
      <email>beth@martinfootandankle.com</email>
    </contact>
    <investigator>
      <last_name>Maria Kasper, DMP</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mt.Olympus Medical Research</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77479</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Management Group</name>
      <address>
        <city>Coto Laurel</city>
        <zip>00780</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</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>
  </condition_browse>
  <!-- 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/NCT04457752
org study id: HITIDE
nct id: NCT04457752
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
A Randomized Controlled Multicenter Clinical Trial, Evaluating the Efficacy of Dual Layer
      Amniotic Membrane (Artacent®) and Standard of Care versus Standard of Care alone in the
      healing Chronic Diabetic Foot Ulcers. Multi-center, open label, randomized controlled trial.
      Study is estimated to require 12 months from first subject enrolled to last subject visit.
Diabetic foot ulcers (DFUs) challenge the most experienced wound care specialist. The US
      Wound Registry reports that only 40% of DFUs heal in 12 weeks1. Woundologists have adopted
      the phrase, "time is tissue." This adage reminds clinicians that the longer a DFU remains
      open, the greater the risk of infection, major amputation and death. The diabetic with a foot
      ulcer has a mortality rate of 47% which exceeds the mortality2 from most common cancers3.
      Beyond patient suffering, the treatment of DFUs cost the US health care system more than 15
      billion dollars annually4.

      In recent years, several clinical trials have demonstrated that products derived from human
      placental membranes promote the healing of DFUs5. Research has confirmed that growth factors
      present in amniotic membrane induce angiogenesis, stimulate human dermal fibroblast
      proliferation, and recruit stem cells important to wound repair and regeneration to the DFU6.
      All these factors are highly desirable properties in the healing of chronic DFUs.

      A novel dual layer amniotic membrane (DLAM, Artacent™, Tides Medical. Lafayette, LA)
      potentially can increase the delivery of growth factors due to its double layer of amniotic
      membrane. A prospective case series demonstrated good healing rates in DFUs: 65% healing at
      12 weeks7. The current study is the first randomized clinical trial evaluating the efficacy
      of DLAM in DFUs.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Dual Layer Amniotic Membrane (DLAM). Artacent® Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized.
Atracent®, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers.
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Wound Closure
time frame: 1-12 weeks
description: - The percentage of target ulcers achieving complete wound closure in 12 weeks
measure: Percentage Wound Area Reduction
time frame: 1-12 weeks
description: - Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry and physical examination
measure: Adverse Events
time frame: 1-12 weeks
description: The number of adverse events
measure: Percentage of time wearing offloading boot
time frame: 1-12 Weeks
description: - Compliance with a prescribed offloading boot measured as % of time wearing the boot
measure: Pain Scale (The Pain, Enjoyment of Life and General Activity Scale). 0 = no pain , 10 = pain as bad as you can imagine
time frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit
description: - Change in pain in the target ulcer assessed using the PEG scale. [Time Frame: TV-1, 3 weeks, 6 weeks, 9 weeks, and 12 weeks or Final Visit]
measure: Changes in bacterial Load
time frame: 1-12 Weeks
description: - Exploratory Endpoint: changes in bacterial load measured using fluorescence imaging
arm group label: Dual Layer Amniotic Membrane (DLAM) + SOC
arm group type: Active Comparator
description: DLAM (Up to 10 weekly DLAM applications) + Standard of Care (sharp debridement, offloading, and proper moisture balance).
arm group label: Standard of Care
arm group type: No Intervention
description: Standard of Care: sharp debridement, offloading, and proper moisture balance.
intervention type: Biological
intervention name: Dual Layer Amniotic Membrane (DLAM). Artacent®
description: Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized.
Atracent®, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers.
arm group label: Dual Layer Amniotic Membrane (DLAM) + SOC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas E Serena, MD,FACS
role: Principal Investigator
affiliation: Serena Group, Inc
last name: Thomas E Serena, MD,FACS
phone: 814-688-4000
email: serena@serenagroups.com
last name: Doug Payne
phone: 888-494-4441
email: dpayne@tidesmedical.com
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer