Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers

Exclusion Criteria

• •Known or suspected disease of the immune system
• •Active or untreated malignancy or active, uncontrolled connective tissue disease
• •Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment
• •Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
• •Has undergone revascularization procedure aimed at increasing blood flow in the treatment target limb \< 4 weeks prior to enrollment
• •Active febrile illness
• •AST, ALT, ALP \>3x the normal upper limit
• •Serum Creatinine \>2x the normal upper limit
• •Osteomyelitis
• •Active Charcot
• •Use of any topical treatments other than SOC (standard of care)at the time of enrollment
• •Enrollment in any investigational clinical trial within 30 days of the screening visit
• •Known or suspected hypersensitivity to any study product components
• •Recent or current history of alcohol or drug abuse
• •Any condition, which in the opinion of the Investigator, would interfere with the evaluation of the study product or poses a health risk to the subject
• •All site personnel directly affiliated with this study and their immediate families