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