Study to Evaluate the Performance and Safety of the Medical Device Argogen

Exclusion Criteria

• •Severe heart (myocardial infarction, myocardial damage, etc.), brain, liver, kidney, lung and other organ disease.
• •Medical history or not-treated diabetes mellitus or diabetic foot syndrome.
• •Peripheral artery disease with ankle brachial index (ABI \< 0.9).
• •Thrombocytopenic patients (platelet \<150.000 g/l; collected in last 3 months medical history).\*
• •Haemoglobin \< 95 g/l (collected in last 3 months medical history).\*
• •Concomitant infection of another site or osteomyelitis or erysipelas or phlegmon.
• •Complicated deep tissue infection requiring systemic antimicrobial therapy.
• •Active viral hepatitis (A/B/C) or active HIV infection or active syphilis.
• •Presence of neoplastic growth in the ulcer.
• •History or clinical signs of impairment of the cochlea or vestibularis system.
• •Neuromuscular diseases (i.e., myasthenia gravis, Parkinson's disease)
• •Aminoglycoside treatment or other antibiotic treatments for chronic venous ulcers administered less than four weeks before inclusion.
• •Concomitant administration of proteolytic enzymes or products containing proteolytic enzymes (i.e., bromelain, chymotrypsin, ficin, papain, serrapeptase, trypsin) during the whole study.
• •Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception\*\* during the study.
• •\*\*Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.).
• •Known allergy to the tested medical device and its components (in particular, allergy to silver).
• •Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalisation during the study.
• •Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
• •* If such lab tests are not available at screening a blood sample can be collected for analyses. However, the patient can be enrolled and start immediately treatment.
• •After Visit 1, the Investigator will examine the laboratory results, as soon as available, to determine patient continuation.