<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/NCT04417647</url>
  </required_header>
  <id_info>
    <org_study_id>G-Wound_01</org_study_id>
    <nct_id>NCT04417647</nct_id>
  </id_info>
  <brief_title>G-Wound (VZ for Wound Treatment)</brief_title>
  <official_title>A Prospective, Randomized, Open-label, Controlled, Exploratory Trial to Investigate the Safety and Tolerability of Topically Administered VZ in Healthy Male Subjects With Artificial Dermal Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glock Health, Science and Research GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Glock Health, Science and Research GmbH</source>
  <oversight_info>
    <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, randomized, open-label, controlled, exploratory trial that aims to&#xD;
      investigate the local skin tolerability of topically administered VZ and to evaluate efficacy&#xD;
      and safety parameters associated with improved wound condition and healing&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Actual">August 13, 2020</completion_date>
  <primary_completion_date type="Actual">July 31, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local tolerability of IMD</measure>
    <time_frame>14 days</time_frame>
    <description>Local tolerability of IMD assessed using erythema severity score: a scale from 0 - 4 (0 = no visible reaction, 1 = faint, minimal erythema, 2 = erhythema, 3 = erythema with induration of vesicles, 4 = severe erythema with induration, vesicles or bullae or pustules and/ulceration) with 0 being best and 4 being worst.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in wound size</measure>
    <time_frame>14 days</time_frame>
    <description>Change in wound size between baseline and End of Treatment (EoT) assessed by photographic analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound closure</measure>
    <time_frame>1 day</time_frame>
    <description>Presence or absence of complete wound closure at End of Treatment (EoT) visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing and condition</measure>
    <time_frame>14 days</time_frame>
    <description>Wound healing and wound condition parameters assessed as a dichotomous outcome by the investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histological evaluation</measure>
    <time_frame>2 days</time_frame>
    <description>Descriptive histological evaluation of wound healing by H&amp;E and Masson trichrome staining as well as by immunostaining against biomarkers of the biopsy specimens obtained at baseline and at EoT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's satisfaction on topical applicability</measure>
    <time_frame>14 days</time_frame>
    <description>Investigator's satisfaction on topical applicability of VZ evaluated via a 5-point Likert scale: a scale from 1 - 5: 5 = extremely satisfied, 4 = very satisfied, 3 = moderately satisfied, 2 = slightly satisfied, 1 = not at all satisfied) with 5 being best and 1 being worst.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in local pain intensity</measure>
    <time_frame>14 days</time_frame>
    <description>Change in local pain intensity based on the Visual Analogue Scale (VAS) when compared to SoC-treated wounds with a scale from 0-10: 0 - no pain and 10 - worst possible pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events and Serious Adverse Events</measure>
    <time_frame>28 days</time_frame>
    <description>Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Wounds</condition>
  <condition>Wound Heal</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Proximal wound SoC treatment - Distal wound VZ application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Distal wound SoC treatment - Proximal wound VZ application</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VZ powder (purified clinoptilolite)</intervention_name>
    <description>VZ powder will be applied topically to the open surface of the verum treatment-assigned wound to cover the entire wound area. Following each VZ application, wounds will be protected by wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective Mepore® dressing).</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard of care (SoC)</intervention_name>
    <description>wound cleansing (0.9% saline solution) and wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective Mepore® dressing) will be applied to the SoC-assigned wound.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male subjects&#xD;
&#xD;
          2. Age 18-45 years at time of screening&#xD;
&#xD;
          3. Subjects are in good clinical and mental health as established by medical history and&#xD;
             physical examination&#xD;
&#xD;
          4. Subject agrees to be compliant with study related visit and treatment schedule&#xD;
&#xD;
          5. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Regular use of medications affecting the blood clotting process (e.g. aspirin or any&#xD;
             other over-the-counter medicine or complimentary health product affecting the blood&#xD;
             clotting process) or immunosuppressive drugs. Aspirin should not be taken in the 10&#xD;
             days prior to study participation or during the study&#xD;
&#xD;
          2. Use of topical (in the skin area of investigation) or systemic antibiotics within the&#xD;
             last 4 weeks before study enrolment&#xD;
&#xD;
          3. History of cancer (except for non-melanoma skin cancer) within the previous 12 months&#xD;
             or treatment with anticancer therapy (chemotherapy, immunotherapy, radiotherapy,&#xD;
             hormone therapy for cancer treatment, targeted therapy or gene therapy) within 12&#xD;
             months before the first administration of investigational product or at any time&#xD;
             during the study&#xD;
&#xD;
          4. Subjects with any known coagulation disorder&#xD;
&#xD;
          5. Subjects who have pigmented skin (Fitzpatrick Classification Level V - VI) due to an&#xD;
             increased susceptibility to hypertrophic and keloid scarring&#xD;
&#xD;
          6. History of wound healing abnormalities or a medical condition that is known to be&#xD;
             associated with abnormal wound healing&#xD;
&#xD;
          7. Chronic inflammatory dermatological disease&#xD;
&#xD;
          8. History of chronic autoimmune diseases such as, but not restricted to rheumatoid&#xD;
             arthritis, inflammatory bowel disease, lupus erythematodes&#xD;
&#xD;
          9. Subjects diagnosed with Diabetes Type I or II&#xD;
&#xD;
         10. Lack of 2-point discrimination above 10 cm as assessed using an aesthesiometer&#xD;
&#xD;
         11. Tattoos, scars, burns, rashes or hyper- or hypopigmentation in the region of planned&#xD;
             punch biopsy&#xD;
&#xD;
         12. Evidence of active infectious disease including HIV and hepatitis B or C&#xD;
&#xD;
         13. Current smoker (or any kind of nicotine consumption)&#xD;
&#xD;
         14. Known allergies to biopsy numbing medication, wound cleansing solution and wound&#xD;
             dressing&#xD;
&#xD;
         15. Known hypersensitivity to aluminium and/or silicon&#xD;
&#xD;
         16. Allergy requiring medical treatment within the last 4 weeks prior to screening&#xD;
&#xD;
         17. Active infection or fever &gt; 38°C within the last 7 days prior to randomization&#xD;
&#xD;
         18. Clinically relevant abnormalities in the laboratory testing, vital signs, ECG or&#xD;
             physical examination&#xD;
&#xD;
         19. Alcohol abuse or a positive urine screen for drugs of abuse at screening&#xD;
&#xD;
         20. Participation in another clinical trial with an investigational day within the last 4&#xD;
             weeks before study participation&#xD;
&#xD;
         21. Employee at the study site, spouse/partner or relative of any study staff (e.g.&#xD;
             investigator, sub-investigators, or study nurse) or relationship to the sponsor&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Wolzt, Prof.Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Clinical Pharmacology, Medical University of Vienna</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Clinical Pharmacology, Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wound</keyword>
  <keyword>Healing</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/NCT04417647
org study id: G-Wound_01
nct id: NCT04417647
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a prospective, randomized, open-label, controlled, exploratory trial that aims to
      investigate the local skin tolerability of topically administered VZ and to evaluate efficacy
      and safety parameters associated with improved wound condition and healing
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local tolerability of IMD
time frame: 14 days
description: Local tolerability of IMD assessed using erythema severity score: a scale from 0 - 4 (0 = no visible reaction, 1 = faint, minimal erythema, 2 = erhythema, 3 = erythema with induration of vesicles, 4 = severe erythema with induration, vesicles or bullae or pustules and/ulceration) with 0 being best and 4 being worst.
measure: Change in wound size
time frame: 14 days
description: Change in wound size between baseline and End of Treatment (EoT) assessed by photographic analysis
measure: Wound closure
time frame: 1 day
description: Presence or absence of complete wound closure at End of Treatment (EoT) visit
measure: Wound healing and condition
time frame: 14 days
description: Wound healing and wound condition parameters assessed as a dichotomous outcome by the investigator
measure: Histological evaluation
time frame: 2 days
description: Descriptive histological evaluation of wound healing by H&E and Masson trichrome staining as well as by immunostaining against biomarkers of the biopsy specimens obtained at baseline and at EoT
measure: Investigator's satisfaction on topical applicability
time frame: 14 days
description: Investigator's satisfaction on topical applicability of VZ evaluated via a 5-point Likert scale: a scale from 1 - 5: 5 = extremely satisfied, 4 = very satisfied, 3 = moderately satisfied, 2 = slightly satisfied, 1 = not at all satisfied) with 5 being best and 1 being worst.
measure: Change in local pain intensity
time frame: 14 days
description: Change in local pain intensity based on the Visual Analogue Scale (VAS) when compared to SoC-treated wounds with a scale from 0-10: 0 - no pain and 10 - worst possible pain.
measure: Adverse Events and Serious Adverse Events
time frame: 28 days
description: Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
arm group label: Group 1
arm group type: Experimental
description: Proximal wound SoC treatment - Distal wound VZ application
arm group label: Group 2
arm group type: Experimental
description: Distal wound SoC treatment - Proximal wound VZ application
intervention type: Device
intervention name: VZ powder (purified clinoptilolite)
description: VZ powder will be applied topically to the open surface of the verum treatment-assigned wound to cover the entire wound area. Following each VZ application, wounds will be protected by wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective Mepore® dressing).
arm group label: Group 1
arm group label: Group 2
intervention type: Procedure
intervention name: Standard of care (SoC)
description: wound cleansing (0.9% saline solution) and wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective Mepore® dressing) will be applied to the SoC-assigned wound.
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Wolzt, Prof.Dr.
role: Principal Investigator
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No