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

NCT06003400 | Active Not Recruiting

• 1 other identifier: TR-21-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (4)

• Safety measured by number of patients who lack adverse events throughout the study.

  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

• 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

Study Arms (1)

Tri.O FITT

EXPERIMENTAL

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); 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

Interventions

Study treatment administration (TriO FITT) DEVICE

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).

Tri.O FITT

Physical Examination DIAGNOSTIC_TEST

physical examination will include an overall examination of the patient's body for any iregular findings and or physical changes from baseline.

Tri.O FITT

Vital Signs DIAGNOSTIC_TEST

vital signs measurement will include blood pressure, pulse and oral temperature as well as hight and weight.

Tri.O FITT

Hematology Blood Tests DIAGNOSTIC_TEST

complete CBC, coagulogram (PT, aPTT); D-dimer; C-reactive protein;; Ferritin; fibrinogen,

Tri.O FITT

Biochemistry Blood Test DIAGNOSTIC_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).

Tri.O FITT

Wound Digital Photography DIAGNOSTIC_TEST

3 photographs of the wound taken before wash, after wash and after treatment.

Tri.O FITT

Urine pregnancy test DIAGNOSTIC_TEST

for women with childbearing potential

Tri.O FITT

Visual Analogue Scale OTHER

Visual Analogue Scale - visual scale scoring 1-10 measuring pain, 10 being worst pain.

Tri.O FITT

SF-36 OTHER

SF-36 - quality of life questionnaire scaling from 0-100, 100 being best quality of life.

Tri.O FITT

Wounds evaluation DIAGNOSTIC_TEST

including size measurements and visual description.

Tri.O FITT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri.O Medical LTD: lead

Study Sites (1)

Hilel Yafe Medical Center

Hadera, Israel

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Physical Examination; Vital Signs

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ronen Ben Ari

  CEO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 22, 2023
• Study Start: March 29, 2023
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)