<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/NCT01715012</url>
  </required_header>
  <id_info>
    <org_study_id>ST-03-12</org_study_id>
    <nct_id>NCT01715012</nct_id>
  </id_info>
  <brief_title>Study of ST266 in Diabetic Subjects With Deep Burns Managed With Skin Grafts</brief_title>
  <official_title>A Phase 2a Randomized, Double Blind, Placebo Controlled, Single-center Study of ST266 Spray in Diabetic Subjects With Deep Burns Managed With Meshed Skin Grafts.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Noveome Biotherapeutics, formerly Stemnion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Noveome Biotherapeutics, formerly Stemnion</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>
      This study is a randomized, double blind, placebo controlled trial at a single site. The&#xD;
      primary objective is to evaluate the safety of ST266 in diabetic subjects with deep burns.&#xD;
      The secondary objectives of this study are to (1) evaluate efficacy of ST266 in healing burns&#xD;
      and (2) evaluate whether treatment with ST266 results in less scarring, in subjects with&#xD;
      diabetes separately comparing healing of the skin graft and the skin graft donor site using&#xD;
      ST266 plus a burn dressing versus placebo and a burn dressing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Enrollment futility&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>Beginning at enrollment and continuing 12 months after last treatment</time_frame>
    <description>The primary objective of this study is to evaluate the safety of ST266 in treating burns in diabetic subjects by evaluating adverse events and serious adverse events. Physical examination, hematology, serum chemistry, urinalysis, vital signs, Adverse Event monitoring, and concomitant medications, cytokine and antibody levels will be monitored at baseline and during the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healing of skin graft</measure>
    <time_frame>Up to 2 weeks of treatment</time_frame>
    <description>Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing the time to complete healing of the skin graft.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healing of skin graft donor site</measure>
    <time_frame>Up to 2 weeks of treatment</time_frame>
    <description>Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing the healing of the skin graft donor site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scarring of skin graft</measure>
    <time_frame>One year following treatment</time_frame>
    <description>Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing scarring of the skin graft at six months and one year using a validated scar scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scarring of skin graft donor site</measure>
    <time_frame>One year following treatment</time_frame>
    <description>Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing scarring of the skin graft donor site at six months and one year using a validated scar scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Third Degree Burns</condition>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>ST266</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ST266 sprayed to the skin graft and donor site</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline (placebo)sprayed to the skin graft and donor site</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ST266</intervention_name>
    <description>ST266 is applied daily by spray to burn wound and skin graft donor site</description>
    <arm_group_label>ST266</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Saline is applied daily by spray to burn wound and skin graft donor site</description>
    <arm_group_label>Saline</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed and dated Institutional Review Board-approved written Informed Consent&#xD;
&#xD;
          -  18 - 75 years of age.&#xD;
&#xD;
          -  Thermal or scald burn, either full thickness or deep partial thickness, which in the&#xD;
             opinion of the burn surgeon, requires a meshed skin graft to heal.&#xD;
&#xD;
          -  Target burn area for treatment equal to or less than three percent total body surface&#xD;
             area.&#xD;
&#xD;
          -  A skin graft site harvested at 10/1000ths of an inch and a skin graft meshed at 2:1.&#xD;
&#xD;
          -  Total Body Surface Area (TBSA) burn of less than or equal to 20 percent total body&#xD;
             surface.&#xD;
&#xD;
          -  Patient must have a known history of diabetes, or be found to have diabetes at the&#xD;
             time of admission, confirmed by a Hemoglobin A1C of greater than 6.5 percent.&#xD;
&#xD;
          -  If a woman of child-bearing potential (WOCBP), she and her partner must be willing to&#xD;
             employ either a highly effective form of birth control (e.g., implants, injectable&#xD;
             medications, a hormone combination oral contraceptive, etc.), sexual abstinence, or a&#xD;
             vasectomised partner, in combination with a barrier method, for the entire duration of&#xD;
             the study (through study discharge). Male subjects with a WOCBP partner must be&#xD;
             willing to use a condom during sexual activity for the entire duration of the study&#xD;
             (through study discharge).&#xD;
&#xD;
          -  Willing to participate in the clinical study and comply with the requirements of the&#xD;
             trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Full thickness burns involving tendon, ligament, bone, or joint capsule.&#xD;
&#xD;
          -  Burns of the face, neck, palmer surface of the hands and plantar surface of the foot.&#xD;
&#xD;
          -  Burn from chemical, electrical or radiation causes.&#xD;
&#xD;
          -  Subjects with any immune deficiency including current treatment with corticosteroid&#xD;
             medication, chemotherapeutic agents, anti-viral therapy, or concurrent radiation&#xD;
             therapy within 30 days of signing the informed consent.&#xD;
&#xD;
          -  Active cancer or a history of cancer in the five years prior to signing the informed&#xD;
             consent form. (History of basal cell carcinoma is allowed).&#xD;
&#xD;
          -  Life expectancy of less than one year.&#xD;
&#xD;
          -  Patients requiring care in the Intensive Care Unit.&#xD;
&#xD;
          -  Inhalation injury requiring mechanical ventilation.&#xD;
&#xD;
          -  Multiple trauma (significant traumatic injury to a solid organ in addition to skin).&#xD;
&#xD;
          -  Psychiatric condition or substance abuse which in the Investigator's opinion may pose&#xD;
             a threat to subject compliance.&#xD;
&#xD;
          -  History of non-compliance with treatment or clinical visit attendance.&#xD;
&#xD;
          -  Participation in an investigational trial within 30 days of study entry.&#xD;
&#xD;
          -  Women who are pregnant or lactating&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Acute clinically significant infection (including viral infections) in the six weeks&#xD;
             prior to administration of study drug or any clinically significant ongoing chronic&#xD;
             infection (excluding fungal infections of the nail beds).&#xD;
&#xD;
          -  Evidence or history of skin conditions that would interfere with evaluations.&#xD;
&#xD;
          -  Any other uncontrolled concomitant disease, condition, or treatment that could&#xD;
             interfere with the conduct of the study, or that would, in the opinion of the&#xD;
             investigator, pose an unacceptable risk to individuals in this study or interfere with&#xD;
             the interpretation of study data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Larry Jones, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Burn Unit of the Wexner Medical Center at The Ohio State University.</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <disposition_first_submitted>November 29, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>November 29, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">November 30, 2016</disposition_first_posted>
  <last_update_submitted>May 9, 2019</last_update_submitted>
  <last_update_submitted_qc>May 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Burn</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Skin graft</keyword>
  <keyword>Donor site</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01715012
org study id: ST-03-12
nct id: NCT01715012
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is a randomized, double blind, placebo controlled trial at a single site. The
      primary objective is to evaluate the safety of ST266 in diabetic subjects with deep burns.
      The secondary objectives of this study are to (1) evaluate efficacy of ST266 in healing burns
      and (2) evaluate whether treatment with ST266 results in less scarring, in subjects with
      diabetes separately comparing healing of the skin graft and the skin graft donor site using
      ST266 plus a burn dressing versus placebo and a burn dressing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety
time frame: Beginning at enrollment and continuing 12 months after last treatment
description: The primary objective of this study is to evaluate the safety of ST266 in treating burns in diabetic subjects by evaluating adverse events and serious adverse events. Physical examination, hematology, serum chemistry, urinalysis, vital signs, Adverse Event monitoring, and concomitant medications, cytokine and antibody levels will be monitored at baseline and during the study.
measure: Healing of skin graft
time frame: Up to 2 weeks of treatment
description: Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing the time to complete healing of the skin graft.
measure: Healing of skin graft donor site
time frame: Up to 2 weeks of treatment
description: Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing the healing of the skin graft donor site.
measure: Scarring of skin graft
time frame: One year following treatment
description: Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing scarring of the skin graft at six months and one year using a validated scar scale.
measure: Scarring of skin graft donor site
time frame: One year following treatment
description: Evaluation of ST266 compared with placebo (saline) in treating burns in diabetic subjects by assessing scarring of the skin graft donor site at six months and one year using a validated scar scale.
arm group label: ST266
arm group type: Experimental
description: ST266 sprayed to the skin graft and donor site
arm group label: Saline
arm group type: Placebo Comparator
description: Saline (placebo)sprayed to the skin graft and donor site
intervention type: Biological
intervention name: ST266
description: ST266 is applied daily by spray to burn wound and skin graft donor site
arm group label: ST266
intervention type: Drug
intervention name: Saline
description: Saline is applied daily by spray to burn wound and skin graft donor site
arm group label: Saline
other name: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Larry Jones, MD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Burns
sharing ipd: No