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

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