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

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

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

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

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).

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

for women with childbearing potential

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

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

including size measurements and visual description.