<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/NCT04438174</url>
  </required_header>
  <id_info>
    <org_study_id>128708</org_study_id>
    <nct_id>NCT04438174</nct_id>
  </id_info>
  <brief_title>Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds</brief_title>
  <official_title>A Phase I/II Clinical Trial To Determine Safety And Feasibility Of Using An Acellular Amniotic Fluid Application To Expedite Healing In Chronic Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective randomized controlled study to determine the safety and feasibility of using&#xD;
      processed amniotic fluid (pAF) to expedite healing in chronic wounds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of our study is to assess, in an outpatient setting, the safety and the time to&#xD;
      wound closure in chronic wounds treated with processed amniotic fluid (pAF). We will include&#xD;
      patients with lower extremity full thickness wounds that are greater than 3 months old and&#xD;
      less than 12 months old. These wounds must have been unresponsive to other therapies, such as&#xD;
      debridement, novel topical dressings, moist dressing, off-loading, and edema control, and the&#xD;
      wound size must be greater than 5cm2 and less than 75 cm2. We will exclude anyone that has a&#xD;
      thermal-related injury (burn or frostbite, etc.) or wounds over joints, requires skin&#xD;
      grafting, or wounds with sinus tracts. Our primary objectives are to determine the safety and&#xD;
      feasibility of using pAF to treat patients with chronic wounds by determining a reduction in&#xD;
      wound size after application of pAF compared to standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2022</start_date>
  <completion_date type="Actual">March 20, 2023</completion_date>
  <primary_completion_date type="Actual">March 20, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Wound digital images will be assessed and evaluated by a University Staff member blinded to both the control and treatment group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Safety - adverse events including serious adverse events</measure>
    <time_frame>Up to 1 year after the last study visit.</time_frame>
    <description>Safety and tolerability will be evaluated by the PI from the results of reported signs and symptoms and scheduled physical examinations. Unresolved AE's will be monitored for 1 year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility - reduction in wound size</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>The percent reduction in wound area at Visit 5 (final visit) relative to the size at randomization visit. Wound surface area will be calculated and maximal wound depth will also be measured using ImageJ overlay software technology.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Wounds and Injuries</condition>
  <arm_group>
    <arm_group_label>Amniotic Fluid Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Processed Amniotic Fluid. Dose is 1ml/5cm2; Route: injected directly into wound; Limited to two injections. The wound will then be dressed according to standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Wound Treatment Regimen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Primary dressings are variable and based on the moisture content and microorganism load. In general, wounds respond differently to various topical treatments. Through our clinical practice, we have found that wounds plateau with the same topical for greater than 4 weeks, hence changing antimicrobial topical helps to manage the bacterial overgrowth. We will start with our application of our slurry, a 1:1:1 ratio of Nystatin ointment, Mupirocin Ointment, and Bacitracin Ointment. This slurry will be applied directly to the cleansed wound, followed by silver gauze/foam product to all wounds. Types of silver product- site and comfort predict use of Restore, Mepilex-AG, or Mepitel-AG. If allergies to the above slurry occurs, we will use medical honey with or without bacitracin. If ointment related rash present with transition to silver product only or silver product plus medical honey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Processed Amniotic Fluid</intervention_name>
    <description>Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area</description>
    <arm_group_label>Amniotic Fluid Injection</arm_group_label>
    <other_name>Processed Amniotic Fluids (pAF)</other_name>
    <other_name>Human Amniotic Fluids (hAF)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care Wound Treatment Regimen</intervention_name>
    <description>ointment-based dressing and non-ointment-based dressings</description>
    <arm_group_label>Standard of Care Wound Treatment Regimen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 18-85 years old.&#xD;
&#xD;
          2. Patients with chronic lower extremity wounds that are greater than 3 months, but less&#xD;
             than 12 months old.&#xD;
&#xD;
          3. Patients with full thickness wounds.&#xD;
&#xD;
          4. Patients with at least one wound that is ≥5 cm2 and&lt;75 cm2 in size.&#xD;
&#xD;
          5. Patients who have failed previous traditional therapies (such as: standard of care,&#xD;
             hyperbaric oxygen therapy, debridement, moist dressings, off-loading and edema&#xD;
             control).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients admitted to the hospital at the time of enrollment.&#xD;
&#xD;
          2. Patients who are pregnant, nursing or plan to become pregnant while participating in&#xD;
             the study. If of child-bearing potential, unwillingness to use effective birth control&#xD;
             while participating in the study.&#xD;
&#xD;
          3. Suspicion of or diagnosis of osteomyelitis underlying the wound.&#xD;
&#xD;
          4. Patients who have received an investigational agent or intervention within the prior&#xD;
             30 days or plan to use within the study period.&#xD;
&#xD;
          5. Patients with thermal-related injuries, such as burns or frostbite or wounds over&#xD;
             joints.&#xD;
&#xD;
          6. Patient with sinus tracts, enterocutaneous fistulas or other epithelialized tracts.&#xD;
&#xD;
          7. Patients who require skin grafting.&#xD;
&#xD;
          8. Patients diagnosed with a highly disruptive, non-controlled mental health disorder&#xD;
             (e.g.., bipolar, or schizophrenia.&#xD;
&#xD;
          9. Patients with a history of prior drug abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giavonni Lewis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Utah</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Utah Burn Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Giavonni Lewis</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>chronic wounds</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT04438174
org study id: 128708
nct id: NCT04438174
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A prospective randomized controlled study to determine the safety and feasibility of using
      processed amniotic fluid (pAF) to expedite healing in chronic wounds.
The goal of our study is to assess, in an outpatient setting, the safety and the time to
      wound closure in chronic wounds treated with processed amniotic fluid (pAF). We will include
      patients with lower extremity full thickness wounds that are greater than 3 months old and
      less than 12 months old. These wounds must have been unresponsive to other therapies, such as
      debridement, novel topical dressings, moist dressing, off-loading, and edema control, and the
      wound size must be greater than 5cm2 and less than 75 cm2. We will exclude anyone that has a
      thermal-related injury (burn or frostbite, etc.) or wounds over joints, requires skin
      grafting, or wounds with sinus tracts. Our primary objectives are to determine the safety and
      feasibility of using pAF to treat patients with chronic wounds by determining a reduction in
      wound size after application of pAF compared to standard of care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Wound digital images will be assessed and evaluated by a University Staff member blinded to both the control and treatment group.
measure: Safety - adverse events including serious adverse events
time frame: Up to 1 year after the last study visit.
description: Safety and tolerability will be evaluated by the PI from the results of reported signs and symptoms and scheduled physical examinations. Unresolved AE's will be monitored for 1 year.
measure: Feasibility - reduction in wound size
time frame: Up to 8 months
description: The percent reduction in wound area at Visit 5 (final visit) relative to the size at randomization visit. Wound surface area will be calculated and maximal wound depth will also be measured using ImageJ overlay software technology.
arm group label: Amniotic Fluid Injection
arm group type: Experimental
description: Processed Amniotic Fluid. Dose is 1ml/5cm2; Route: injected directly into wound; Limited to two injections. The wound will then be dressed according to standard of care.
arm group label: Standard of Care Wound Treatment Regimen
arm group type: Active Comparator
description: Primary dressings are variable and based on the moisture content and microorganism load. In general, wounds respond differently to various topical treatments. Through our clinical practice, we have found that wounds plateau with the same topical for greater than 4 weeks, hence changing antimicrobial topical helps to manage the bacterial overgrowth. We will start with our application of our slurry, a 1:1:1 ratio of Nystatin ointment, Mupirocin Ointment, and Bacitracin Ointment. This slurry will be applied directly to the cleansed wound, followed by silver gauze/foam product to all wounds. Types of silver product- site and comfort predict use of Restore, Mepilex-AG, or Mepitel-AG. If allergies to the above slurry occurs, we will use medical honey with or without bacitracin. If ointment related rash present with transition to silver product only or silver product plus medical honey.
intervention type: Drug
intervention name: Processed Amniotic Fluid
description: Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area
arm group label: Amniotic Fluid Injection
other name: Processed Amniotic Fluids (pAF)
other name: Human Amniotic Fluids (hAF)
intervention type: Other
intervention name: Standard of Care Wound Treatment Regimen
description: ointment-based dressing and non-ointment-based dressings
arm group label: Standard of Care Wound Treatment Regimen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Giavonni Lewis, MD
role: Principal Investigator
affiliation: University of Utah
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Giavonni Lewis
investigator title: MD
mesh term: Wounds and Injuries
sharing ipd: No