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

• 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).
• 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.
• Vital Signs (Diagnostic test): vital signs measurement will include blood pressure, pulse and oral temperature as well as hight and weight.
• Hematology Blood Tests (Diagnostic test): complete CBC, coagulogram (PT, aPTT); D-dimer; C-reactive protein;; Ferritin; fibrinogen,
• 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).
• Wound Digital Photography (Diagnostic test): 3 photographs of the wound taken before wash, after wash and after treatment.
• Urine pregnancy test (Diagnostic test): for women with childbearing potential
• Visual Analogue Scale (Other): Visual Analogue Scale - visual scale scoring 1-10 measuring pain, 10 being worst pain.
• SF-36 (Other): SF-36 - quality of life questionnaire scaling from 0-100, 100 being best quality of life.
• Wounds evaluation (Diagnostic test): including size measurements and visual description.

Primary outcomes

• 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 [0 to 28 weeks]: pain levels will be measured by the precent of change in VAS pain raiting scale.
• Change in Quality of life (QoL) between visits 1 and the last treatment, measured by SF-36 [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 [0 to 28 weeks]: change in size (cm\^2)

Sex: All, ages: 18 Years to 80 Years

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

• Ronen Ben Ari, Study director, CEO