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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: 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: Visual Analogue Scale; Other: SF-36; Diagnostic test: Wounds evaluation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel
    • Hilel Yafe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tri.O Medical LTD
• Investigators: Study Director: Ronen Ben Ari, CEO

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination; Vital Signs
• Other Study ID Numbers: TR-21-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No