xml: <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/NCT06036485</url>
    </required_header>
    <id_info>
      <org_study_id>Kerecis-1</org_study_id>
      <nct_id>NCT06036485</nct_id>
    </id_info>
    <brief_title>Efficacy of Kerecis Omega 3 in Comparison to Clinical Standard Procedures</brief_title>
    <official_title>Efficacy of Kerecis Omega 3 Versus Standard of Care in Patients With Chronic Leg Ulcerations - a Randomized Trial With a New In-wound Split Design Approach</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Insel Gruppe AG, University Hospital Bern</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Insel Gruppe AG, University Hospital Bern</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>
        Chronic leg ulcerations are a great burden for patients and the medical system alike.&#xD;
        Frequent outpatient consultations with associated treatment costs and travel costs for the&#xD;
        patient as well as psychosocial burdens remain an unmet problem in chronic wound care. There&#xD;
        is an increasing need for definitive treatment of especially chronic venous and&#xD;
        multifactorial chronic leg ulceration where arterial intervention is not a treatment option.&#xD;
  &#xD;
        Minimal invasive surgical interventions that do not require skin grafting can be performed&#xD;
        under local anesthesia in an outpatient setting even in multimorbid patients.&#xD;
  &#xD;
        Kerecis Omega3 Wound is intact decellularized fish skin. The fish skin sheets contain fat,&#xD;
        protein, elastin, glycans and other natural skin elements and it can be an effective&#xD;
        treatment option in chronic leg ulcerations and is licensed for this use as a medical product&#xD;
        in Switzerland. However, limited data without inter-wound bias is available for the use of&#xD;
        Kerecis Omega 3 in chronic leg ulcerations.&#xD;
  &#xD;
        In this study the investigators propose to investigate the efficacy of Kerecis Omega 3&#xD;
        according to objective wound surface measurements using standardized digital photographs in&#xD;
        patients with chronic leg ulcerations. Efficacy will be evaluated against standard of care&#xD;
        wound debridement.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Withdrawn</overall_status>
    <why_stopped>
      Lack of funding to support the study&#xD;
    </why_stopped>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Actual">May 1, 2023</completion_date>
    <primary_completion_date type="Actual">May 1, 2023</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>
      <intervention_model_description>1:1 in-wound split design with random allocation</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in ulcer surface area</measure>
      <time_frame>12 weeks</time_frame>
      <description>Change in ulcer surface area as assessed by standardized photography and digital imaging.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in patient quality of life</measure>
      <time_frame>2, 4, 6 and 12 weeks</time_frame>
      <description>Change in patient quality of life as assessed by the Wound-QoL questionnaire score, ranging from 0 to 4, with higher scores indicating a worse quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in wound microbiota as assessed by alpha diversity of the microbial composition</measure>
      <time_frame>2, 4, 6 and 12 weeks</time_frame>
      <description>Change in wound microbiota utilizing 16S-sequencing from wound swabs as assessed by alpha diversity of the microbial composition trough Shannon index, with higher scores indicating a more diversity of the species</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in wound microbiota as assessed by beta diversity of the microbial composition</measure>
      <time_frame>2, 4, 6 and 12 weeks</time_frame>
      <description>Change in wound microbiota utilizing 16S-sequencing from wound swabs as assessed by beta diversity of the microbial composition trough Shannon index, with higher scores indicating a more diversity of the species.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ulcer surface area</measure>
      <time_frame>2, 4, 6 and 12 weeks</time_frame>
      <description>Change in ulcer surface area as assessed by standardized photography and digital imaging.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>12 weeks</time_frame>
      <description>Cumulative incidence of treatment-related adverse events</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">0</enrollment>
    <condition>Leg Ulcer</condition>
    <arm_group>
      <arm_group_label>Kerecis Omega 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Surgical debridement</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Kerecis Omega 3</intervention_name>
      <description>Decellularized intact fish skin developed for the management of chronic wounds</description>
      <arm_group_label>Kerecis Omega 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Surgical debridement</intervention_name>
      <description>Superficial sharp surgical debridement technique</description>
      <arm_group_label>Surgical debridement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Any chronic leg ulcer &gt; 4 weeks duration with delayed wound healing (reduction of&#xD;
               wound surface of less than 40-50% within 4 weeks under adequate local therapy) without&#xD;
               underlying treatable medical conditions&#xD;
  &#xD;
            -  Ulcer area at between 5cm2 and 60cm2&#xD;
  &#xD;
            -  Bacterial swab sampling prior to study&#xD;
  &#xD;
            -  Written study informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of Fish allergy or proven Fish allergy&#xD;
  &#xD;
            -  Pregnant or breast-feeding women&#xD;
  &#xD;
            -  Intention to become pregnant during the course of the study&#xD;
  &#xD;
            -  Wound not suitable for dressing: inflammation, fibrin coatings&#xD;
  &#xD;
            -  Inability to understand the study consent&#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>Simon Bossart, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of dermatology, University Hospital Inselspital, Bern</affiliation>
    </overall_official>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 15, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</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>Leg 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>
  
  
text: 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/NCT06036485
  org study id: Kerecis-1
  nct id: NCT06036485
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Chronic leg ulcerations are a great burden for patients and the medical system alike.
        Frequent outpatient consultations with associated treatment costs and travel costs for the
        patient as well as psychosocial burdens remain an unmet problem in chronic wound care. There
        is an increasing need for definitive treatment of especially chronic venous and
        multifactorial chronic leg ulceration where arterial intervention is not a treatment option.
  
        Minimal invasive surgical interventions that do not require skin grafting can be performed
        under local anesthesia in an outpatient setting even in multimorbid patients.
  
        Kerecis Omega3 Wound is intact decellularized fish skin. The fish skin sheets contain fat,
        protein, elastin, glycans and other natural skin elements and it can be an effective
        treatment option in chronic leg ulcerations and is licensed for this use as a medical product
        in Switzerland. However, limited data without inter-wound bias is available for the use of
        Kerecis Omega 3 in chronic leg ulcerations.
  
        In this study the investigators propose to investigate the efficacy of Kerecis Omega 3
        according to objective wound surface measurements using standardized digital photographs in
        patients with chronic leg ulcerations. Efficacy will be evaluated against standard of care
        wound debridement.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 1:1 in-wound split design with random allocation
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in ulcer surface area
  time frame: 12 weeks
  description: Change in ulcer surface area as assessed by standardized photography and digital imaging.
  measure: Change in patient quality of life
  time frame: 2, 4, 6 and 12 weeks
  description: Change in patient quality of life as assessed by the Wound-QoL questionnaire score, ranging from 0 to 4, with higher scores indicating a worse quality of life.
  measure: Change in wound microbiota as assessed by alpha diversity of the microbial composition
  time frame: 2, 4, 6 and 12 weeks
  description: Change in wound microbiota utilizing 16S-sequencing from wound swabs as assessed by alpha diversity of the microbial composition trough Shannon index, with higher scores indicating a more diversity of the species
  measure: Change in wound microbiota as assessed by beta diversity of the microbial composition
  time frame: 2, 4, 6 and 12 weeks
  description: Change in wound microbiota utilizing 16S-sequencing from wound swabs as assessed by beta diversity of the microbial composition trough Shannon index, with higher scores indicating a more diversity of the species.
  measure: Change in ulcer surface area
  time frame: 2, 4, 6 and 12 weeks
  description: Change in ulcer surface area as assessed by standardized photography and digital imaging.
  measure: Incidence of adverse events
  time frame: 12 weeks
  description: Cumulative incidence of treatment-related adverse events
  arm group label: Kerecis Omega 3
  arm group type: Experimental
  arm group label: Surgical debridement
  arm group type: Active Comparator
  intervention type: Device
  intervention name: Kerecis Omega 3
  description: Decellularized intact fish skin developed for the management of chronic wounds
  arm group label: Kerecis Omega 3
  intervention type: Procedure
  intervention name: Surgical debridement
  description: Superficial sharp surgical debridement technique
  arm group label: Surgical debridement
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Simon Bossart, MD
  role: Principal Investigator
  affiliation: Department of dermatology, University Hospital Inselspital, Bern
  responsible party type: Sponsor
  mesh term: Leg Ulcer
  sharing ipd: No