Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients (TriO FITT)

• ClinicalTrials.gov Identifier: NCT06003400
• Recruitment Status: Recruiting
• First Posted: August 22, 2023
• Last Update Posted: August 22, 2023
• Sponsor: Tri.O Medical LTD
• Information provided by (Responsible Party): Tri.O Medical LTD

Tracking Information

• First Submitted Date: July 25, 2023
• First Posted Date: August 22, 2023
• Last Update Posted Date: August 22, 2023
• Actual Study Start Date: March 29, 2023
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 21, 2023)

• Safety measured by number of patients who lack adverse events throughout the study. [ Time Frame: 0 to 28 weeks ]
• Change in pain level between visits 1 and the last treatment evaluated by VAS & NRS scales [ Time Frame: 0 to 28 weeks ]
  pain levels will be measured by the precent of change in both pain raiting scales.
• Change in Quality of life (QoL) between visits 1 and the last treatment, measured by SF-36 [ Time Frame: 0 to 28 weeks ]
  score measures from 0 to 100, 100 being good quality of life.
• Change in wound size between V1 and the last treatment [ Time Frame: 0 to 28 weeks ]
  change in size (cm^2)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients
• Official Title: Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Administration of Tri.O FITT for upto 12 weeks or until wound closure.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Diabetic Foot Ulcer

Intervention

• Device: Study treatment administration (TriO FITT)
  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).
• Diagnostic Test: Physical Examination
  physical examination will include an overall examination of the patient's body for any iregular findings and or physical changes from baseline.
• Diagnostic Test: Vital Signs
  vital signs measurement will include blood pressure, pulse and oral temperature as well as hight and weight.
• Diagnostic Test: Hematology Blood Tests
  complete CBC, coagulogram (PT, aPTT); D-dimer; C-reactive protein;; Ferritin; fibrinogen,
• Diagnostic Test: Biochemistry Blood Test
  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).
• Diagnostic Test: Wound Digital Photography
  3 photographs of the wound taken before wash, after wash and after treatment.
• Diagnostic Test: Urine pregnancy test
  for women with childbearing potential
• Other: Numeric Pain Rating Scale
  Numeric Pain Rating Scale - numeral scale from 1 to 10 measuring pain, 10 being worst pain.
• Other: Visual Analogue Scale
  Visual Analogue Scale - visual scale scoring 1-10 measuring pain, 10 being worst pain.
• Other: SF-36
  SF-36 - quality of life questionnaire scaling from 0-100, 100 being best quality of life.
• Diagnostic Test: Wounds evaluation
  including size measurements and visual description.

Study Arms

Experimental: Tri.O FITT

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.

Interventions:

• Device: Study treatment administration (TriO FITT)
• Diagnostic Test: Physical Examination
• Diagnostic Test: Vital Signs
• Diagnostic Test: Hematology Blood Tests
• Diagnostic Test: Biochemistry Blood Test
• Diagnostic Test: Wound Digital Photography
• Diagnostic Test: Urine pregnancy test
• Other: Numeric Pain Rating Scale
• Other: Visual Analogue Scale
• Other: SF-36
• Diagnostic Test: Wounds evaluation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 21, 2023): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2025
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Males and females 18-80 years old
• Chronic Diabetes Mellitus type 1 and type 2 diagnosed at least 3 years before the screening
• Have a single non-infected diabetic hard-to-heal wound (ulcers/foot ulcers) ≤ 0.8-40 cm2 wound area at start of treatment, for period of at least for 3 months.
• Wagner classification stage 1 or 2 or post-debridement stage 3.
• At least moderate blood perfusion into the affected limb as defined by Ankle Brachial Index (ABI) ≥0.65
• Stable diabetic drugs 4 weeks before Screening
• Be available for the entire study period, and be able and willing to adhere to protocol requirements
• Provide written informed consent prior to admission into the study

Exclusion Criteria:

• Have a glycosylated hemoglobin (HbA1c) > 10.5%
• Have more than one wound
• Have a body mass index (BMI) > 40 kg/m2
• Have visible bone exposure at wound site
• Anemia (Hemoglobin < 9 g/dL) or White Blood Cells count > 11,000/μL or Platelets count < 100,000/μL or liver function tests > 3 times upper normal lab values or Creatinine > 3 mg/dL; any indication of malnourishment (Albumin < 3 g/dL); INR>2 or any other clinically significant blood and urinalysis tests per the physician's discretion
• Patients with unstable hypertension
• Have any clinically significant chronic or acute illness during the 4 weeks prior to admission into the study, except diabetes type 1 or 2 or during screening period
• Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years, not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test
• Participation in a clinical study or use of an investigational drug within 30 days prior to admission to this study
• Patients with active Gangrenous foot ulcers
• Active osteomyelitis (Have any signs of infection in the wound (which could be linked to raised body temperature), abscess, cellulitis, necrosis, erythema, mild drainage or known osteomyelitis)
• Patients with uncontrolled hyperthyroidism
• Patients with history of collagen diseases
• Patients with known allergy to ozone
• Anxiety, Depression, history of Mental illness or patient under Guardian
• Any medical condition for which the investigator deems the subject unable to participate in the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ronen Ben Ari; +972525605209; Ronen@trio-medical.com

• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT06003400
• Other Study ID Numbers: TR-21-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Tri.O Medical LTD
• Original Responsible Party: Same as current
• Current Study Sponsor: Tri.O Medical LTD
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Ronen Ben Ari; CEO

• PRS Account: Tri.O Medical LTD
• Verification Date: August 2023