<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/NCT03044132</url>
  </required_header>
  <id_info>
    <org_study_id>CR-16-002</org_study_id>
    <nct_id>NCT03044132</nct_id>
  </id_info>
  <brief_title>DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers</brief_title>
  <official_title>A Prospective Trial Measuring the Clinical Outcomes for DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LifeNet Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LifeNet Health</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes&#xD;
      of DermACELL AWM in dermal regeneration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical evaluation with DermACELL AWM will explore its use in the treatment of complex&#xD;
      soft tissue defects involving muscle, fascia, tendon, or bone exposure (Wagner Classification&#xD;
      3 and 4).&#xD;
&#xD;
      A total of 50 subjects will be treated with DermACELL AWM in the operating room for coverage&#xD;
      of deep soft tissue defects in the lower extremity. Subjects will then be followed in the&#xD;
      outpatient clinic for up to 16 weeks.&#xD;
&#xD;
      The specific aim of the study is to assess the ability of the product to sustain an optimal&#xD;
      dermal layer. The time (days) required for wound bed preparation (granular bed after&#xD;
      placement of DermACELL AWM) and safety data will be collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>
    <intervention_model_description>Prospective, multicenter post market product evaluation of study product for deep wounds of the lower extremity</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).</measure>
    <time_frame>112 Days</time_frame>
    <description>Days required for granular bed formation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of applications of study product required to achieve granulation.</measure>
    <time_frame>16 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent wound area reduction and percent complete wound closure at 16 Weeks.</measure>
    <time_frame>16 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation.</measure>
    <time_frame>16 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Diabetic Foot Ulcer</condition>
  <condition>Lower Extremity Wound</condition>
  <arm_group>
    <arm_group_label>DermACELL AWM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Human acellular dermal matrix (ADM) recovered from human donors, decellularized, provided with at least 97% DNA removal, terminally sterilized in its final package, and ready to use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DermACELL AWM</intervention_name>
    <description>Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology</description>
    <arm_group_label>DermACELL AWM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Wagner Grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue&#xD;
             (exposed fascia, ligament, tendon, muscle, or bone)&#xD;
&#xD;
          -  target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks&#xD;
             but not greater than 1 year in duration)&#xD;
&#xD;
          -  target wound that is not amendable to primary closure&#xD;
&#xD;
          -  target wound deemed without any residual infection (as assessed by Investigator) or is&#xD;
             being treated upon entry into the clinical trial&#xD;
&#xD;
          -  adequate perfusion to the extremity&#xD;
&#xD;
          -  laboratory assessments which represent a good potential for wound healing (liver and&#xD;
             kidney function, nutritionally stable and diabetes control)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  untreated infection of soft tissue or bone&#xD;
&#xD;
          -  untreated autoimmune connective tissue disorders&#xD;
&#xD;
          -  body mass index (BMI) of ≥ 50&#xD;
&#xD;
          -  undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication&#xD;
&#xD;
          -  active liver disease (e.g. hepatitis A-G),&#xD;
&#xD;
          -  have undergone previous wound care therapy that included any bioengineered alternative&#xD;
             tissue or STSG 30 days prior to enrollment&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  enrolled in any other interventional clinical research trial&#xD;
&#xD;
          -  an increase or decrease of more than 25% in wound area or volume from the Screening to&#xD;
             Baseline visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Limb Preservation Platform</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Purvis Moyer Foot and Ankle Center</name>
      <address>
        <city>Rocky Mount</city>
        <state>North Carolina</state>
        <zip>27804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Cazzell S, Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA. A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Adv Skin Wound Care. 2019 Sep;32(9):409-415. doi: 10.1097/01.ASW.0000569132.38449.c0.</citation>
    <PMID>31361269</PMID>
  </results_reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>September 3, 2019</last_update_submitted>
  <last_update_submitted_qc>September 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetic Foot Ulcer</keyword>
  <keyword>DFU</keyword>
  <keyword>Lower Extremity Wound</keyword>
  <keyword>Skin Substitute</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/NCT03044132
org study id: CR-16-002
nct id: NCT03044132
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes
      of DermACELL AWM in dermal regeneration.
This clinical evaluation with DermACELL AWM will explore its use in the treatment of complex
      soft tissue defects involving muscle, fascia, tendon, or bone exposure (Wagner Classification
      3 and 4).

      A total of 50 subjects will be treated with DermACELL AWM in the operating room for coverage
      of deep soft tissue defects in the lower extremity. Subjects will then be followed in the
      outpatient clinic for up to 16 weeks.

      The specific aim of the study is to assess the ability of the product to sustain an optimal
      dermal layer. The time (days) required for wound bed preparation (granular bed after
      placement of DermACELL AWM) and safety data will be collected.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, multicenter post market product evaluation of study product for deep wounds of the lower extremity
primary purpose: Treatment
masking: None (Open Label)
measure: Time (days) required for wound bed preparation (granular bed after placement of DermACELL AWM).
time frame: 112 Days
description: Days required for granular bed formation
measure: Number of applications of study product required to achieve granulation.
time frame: 16 Weeks
measure: Percent wound area reduction and percent complete wound closure at 16 Weeks.
time frame: 16 Weeks
measure: The number of adverse events after DermACELL AWM application including infection, hospitalization, and reoperation.
time frame: 16 Weeks
arm group label: DermACELL AWM
arm group type: Experimental
description: Human acellular dermal matrix (ADM) recovered from human donors, decellularized, provided with at least 97% DNA removal, terminally sterilized in its final package, and ready to use.
intervention type: Other
intervention name: DermACELL AWM
description: Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology
arm group label: DermACELL AWM
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
country: United States
citation: Cazzell S, Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA. A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Adv Skin Wound Care. 2019 Sep;32(9):409-415. doi: 10.1097/01.ASW.0000569132.38449.c0.
PMID: 31361269
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Foot Ulcer
mesh term: Ulcer
sharing ipd: No