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/NCT06003400</url>
    </required_header>
    <id_info>
      <org_study_id>TR-21-01</org_study_id>
      <nct_id>NCT06003400</nct_id>
    </id_info>
    <brief_title>Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the &quot;FITT&quot; Device in Diabetic Foot Ulcers Patients</brief_title>
    <acronym>TriO FITT</acronym>
    <official_title>Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the &quot;FITT&quot; Device in Diabetic Foot Ulcers Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tri.O Medical LTD</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tri.O Medical LTD</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>
        The TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers.&#xD;
  &#xD;
        The mechanism of action of the device optimizes and combines the administration known&#xD;
        supproting treatments to chronic diabetic ulcers. The treatment is astimated to improve the&#xD;
        wound conditions of acute and chronic diabetic wounds.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 29, 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Administration of Tri.O FITT for upto 12 weeks or until wound closure.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety measured by number of patients who lack adverse events throughout the study.</measure>
      <time_frame>0 to 28 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in pain level between visits 1 and the last treatment evaluated by VAS &amp; NRS scales</measure>
      <time_frame>0 to 28 weeks</time_frame>
      <description>pain levels will be measured by the precent of change in both pain raiting scales.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Quality of life (QoL) between visits 1 and the last treatment, measured by SF-36</measure>
      <time_frame>0 to 28 weeks</time_frame>
      <description>score measures from 0 to 100, 100 being good quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in wound size between V1 and the last treatment</measure>
      <time_frame>0 to 28 weeks</time_frame>
      <description>change in size (cm^2)</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Diabetic Foot Ulcer</condition>
    <arm_group>
      <arm_group_label>Tri.O FITT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The study patients will undergo a screening period of upto 4 weeks, a traetment period of upto 12 weeks and a follow-up period of upto 12 additional weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Study treatment administration (TriO FITT)</intervention_name>
      <description>Patients will be treated with the study device 2-3 times per week (determined by their wagner score) for an hour at each visit. treatment will include a combination of methods (the exact details is patented by the company and can not be elaborated).</description>
      <arm_group_label>Tri.O FITT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Physical Examination</intervention_name>
      <description>physical examination will include an overall examination of the patient's body for any iregular findings and or physical changes from baseline.</description>
      <arm_group_label>Tri.O FITT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Vital Signs</intervention_name>
      <description>vital signs measurement will include blood pressure, pulse and oral temperature as well as hight and weight.</description>
      <arm_group_label>Tri.O FITT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Hematology Blood Tests</intervention_name>
      <description>complete CBC, coagulogram (PT, aPTT); D-dimer; C-reactive protein;; Ferritin; fibrinogen,</description>
      <arm_group_label>Tri.O FITT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Biochemistry Blood Test</intervention_name>
      <description>urea, creatinine, uric acid, sodium, potassium, chloride, calcium, glucose, glycated hemoglobin, alkaline phosphatase (FA), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and fractions ( BTF), total proteins and fractions (PTF), lipid profile (total cholesterol, fractions and triglycerides).</description>
      <arm_group_label>Tri.O FITT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Wound Digital Photography</intervention_name>
      <description>3 photographs of the wound taken before wash, after wash and after treatment.</description>
      <arm_group_label>Tri.O FITT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Urine pregnancy test</intervention_name>
      <description>for women with childbearing potential</description>
      <arm_group_label>Tri.O FITT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Numeric Pain Rating Scale</intervention_name>
      <description>Numeric Pain Rating Scale - numeral scale from 1 to 10 measuring pain, 10 being worst pain.</description>
      <arm_group_label>Tri.O FITT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Visual Analogue Scale</intervention_name>
      <description>Visual Analogue Scale - visual scale scoring 1-10 measuring pain, 10 being worst pain.</description>
      <arm_group_label>Tri.O FITT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>SF-36</intervention_name>
      <description>SF-36 - quality of life questionnaire scaling from 0-100, 100 being best quality of life.</description>
      <arm_group_label>Tri.O FITT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Wounds evaluation</intervention_name>
      <description>including size measurements and visual description.</description>
      <arm_group_label>Tri.O FITT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males and females 18-80 years old&#xD;
  &#xD;
            -  Chronic Diabetes Mellitus type 1 and type 2 diagnosed at least 3 years before the&#xD;
               screening&#xD;
  &#xD;
            -  Have a single non-infected diabetic hard-to-heal wound (ulcers/foot ulcers) ≤ 0.8-40&#xD;
               cm2 wound area at start of treatment, for period of at least for 3 months.&#xD;
  &#xD;
            -  Wagner classification stage 1 or 2 or post-debridement stage 3.&#xD;
  &#xD;
            -  At least moderate blood perfusion into the affected limb as defined by Ankle Brachial&#xD;
               Index (ABI) ≥0.65&#xD;
  &#xD;
            -  Stable diabetic drugs 4 weeks before Screening&#xD;
  &#xD;
            -  Be available for the entire study period, and be able and willing to adhere to&#xD;
               protocol requirements&#xD;
  &#xD;
            -  Provide written informed consent prior to admission into the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have a glycosylated hemoglobin (HbA1c) &gt; 10.5%&#xD;
  &#xD;
            -  Have more than one wound&#xD;
  &#xD;
            -  Have a body mass index (BMI) &gt; 40 kg/m2&#xD;
  &#xD;
            -  Have visible bone exposure at wound site&#xD;
  &#xD;
            -  Anemia (Hemoglobin &lt; 9 g/dL) or White Blood Cells count &gt; 11,000/μL or Platelets count&#xD;
               &lt; 100,000/μL or liver function tests &gt; 3 times upper normal lab values or Creatinine &gt;&#xD;
               3 mg/dL; any indication of malnourishment (Albumin &lt; 3 g/dL); INR&gt;2 or any other&#xD;
               clinically significant blood and urinalysis tests per the physician's discretion&#xD;
  &#xD;
            -  Patients with unstable hypertension&#xD;
  &#xD;
            -  Have any clinically significant chronic or acute illness during the 4 weeks prior to&#xD;
               admission into the study, except diabetes type 1 or 2 or during screening period&#xD;
  &#xD;
            -  Females who are pregnant, lactating, of child-bearing potential, or post-menopausal&#xD;
               for less than 2 years, not using a medically approved method of contraception (i.e.,&#xD;
               oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm,&#xD;
               condom, abstinence, or surgical sterility), or females who test positive on a&#xD;
               urine-based pregnancy test&#xD;
  &#xD;
            -  Participation in a clinical study or use of an investigational drug within 30 days&#xD;
               prior to admission to this study&#xD;
  &#xD;
            -  Patients with active Gangrenous foot ulcers&#xD;
  &#xD;
            -  Active osteomyelitis (Have any signs of infection in the wound (which could be linked&#xD;
               to raised body temperature), abscess, cellulitis, necrosis, erythema, mild drainage or&#xD;
               known osteomyelitis)&#xD;
  &#xD;
            -  Patients with uncontrolled hyperthyroidism&#xD;
  &#xD;
            -  Patients with history of collagen diseases&#xD;
  &#xD;
            -  Patients with known allergy to ozone&#xD;
  &#xD;
            -  Anxiety, Depression, history of Mental illness or patient under Guardian&#xD;
  &#xD;
            -  Any medical condition for which the investigator deems the subject unable to&#xD;
               participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ronen Ben Ari</last_name>
      <role>Study Director</role>
      <affiliation>CEO</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ronen Ben Ari</last_name>
      <phone>+972525605209</phone>
      <email>Ronen@trio-medical.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hilel Yafe Medical Center</name>
        <address>
          <city>Hadera</city>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maxim Gurevich, Dr.</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 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>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>
  
  
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/NCT06003400
  org study id: TR-21-01
  nct id: NCT06003400
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers.
  
        The mechanism of action of the device optimizes and combines the administration known
        supproting treatments to chronic diabetic ulcers. The treatment is astimated to improve the
        wound conditions of acute and chronic diabetic wounds.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Administration of Tri.O FITT for upto 12 weeks or until wound closure.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety measured by number of patients who lack adverse events throughout the study.
  time frame: 0 to 28 weeks
  measure: Change in pain level between visits 1 and the last treatment evaluated by VAS & NRS scales
  time frame: 0 to 28 weeks
  description: pain levels will be measured by the precent of change in both pain raiting scales.
  measure: Change in Quality of life (QoL) between visits 1 and the last treatment, measured by SF-36
  time frame: 0 to 28 weeks
  description: score measures from 0 to 100, 100 being good quality of life.
  measure: Change in wound size between V1 and the last treatment
  time frame: 0 to 28 weeks
  description: change in size (cm^2)
  arm group label: Tri.O FITT
  arm group type: Experimental
  description: The study patients will undergo a screening period of upto 4 weeks, a traetment period of upto 12 weeks and a follow-up period of upto 12 additional weeks.
  intervention type: Device
  intervention name: Study treatment administration (TriO FITT)
  description: Patients will be treated with the study device 2-3 times per week (determined by their wagner score) for an hour at each visit. treatment will include a combination of methods (the exact details is patented by the company and can not be elaborated).
  arm group label: Tri.O FITT
  intervention type: Diagnostic Test
  intervention name: Physical Examination
  description: physical examination will include an overall examination of the patient's body for any iregular findings and or physical changes from baseline.
  arm group label: Tri.O FITT
  intervention type: Diagnostic Test
  intervention name: Vital Signs
  description: vital signs measurement will include blood pressure, pulse and oral temperature as well as hight and weight.
  arm group label: Tri.O FITT
  intervention type: Diagnostic Test
  intervention name: Hematology Blood Tests
  description: complete CBC, coagulogram (PT, aPTT); D-dimer; C-reactive protein;; Ferritin; fibrinogen,
  arm group label: Tri.O FITT
  intervention type: Diagnostic Test
  intervention name: Biochemistry Blood Test
  description: urea, creatinine, uric acid, sodium, potassium, chloride, calcium, glucose, glycated hemoglobin, alkaline phosphatase (FA), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and fractions ( BTF), total proteins and fractions (PTF), lipid profile (total cholesterol, fractions and triglycerides).
  arm group label: Tri.O FITT
  intervention type: Diagnostic Test
  intervention name: Wound Digital Photography
  description: 3 photographs of the wound taken before wash, after wash and after treatment.
  arm group label: Tri.O FITT
  intervention type: Diagnostic Test
  intervention name: Urine pregnancy test
  description: for women with childbearing potential
  arm group label: Tri.O FITT
  intervention type: Other
  intervention name: Numeric Pain Rating Scale
  description: Numeric Pain Rating Scale - numeral scale from 1 to 10 measuring pain, 10 being worst pain.
  arm group label: Tri.O FITT
  intervention type: Other
  intervention name: Visual Analogue Scale
  description: Visual Analogue Scale - visual scale scoring 1-10 measuring pain, 10 being worst pain.
  arm group label: Tri.O FITT
  intervention type: Other
  intervention name: SF-36
  description: SF-36 - quality of life questionnaire scaling from 0-100, 100 being best quality of life.
  arm group label: Tri.O FITT
  intervention type: Diagnostic Test
  intervention name: Wounds evaluation
  description: including size measurements and visual description.
  arm group label: Tri.O FITT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Ronen Ben Ari
  role: Study Director
  affiliation: CEO
  last name: Ronen Ben Ari
  phone: +972525605209
  email: Ronen@trio-medical.com
  facility: 
  status: Recruiting
  contact: 
  country: Israel
  responsible party type: Sponsor
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  mesh term: Ulcer
  sharing ipd: No