Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers

Exclusion Criteria

• •1. Visible signs of infection, black necrosis or discharge in the target ulcer.
• •2. More than \~20% slough after debridement.
• •3. Ulcer that by location or extension will either be difficult to follow or to treat according to the protocol.
• •4. Other known etiology of the target ulcer.
• •5. Subject having to the discretion of the investigator clinically significant findings on physical examination or vital signs.
• •6. Concomitant systemic or topical treatment within 14 days prior to start of study medication with antibiotics or antiseptics for treatment of ulcer infection in target ulcer.
• •7. Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives
• •8. Concomitant topical treatment within 14 days prior to start of study medication with any of the following:
• •* NSAIDs, aspirin
• •* Growth factors, or other biologically active agents
• •* Products containing chlorhexidine, potassium permanganate, iodine or silver
• •9. Diabetes Mellitus requiring pharmaceutical treatment.
• •10. Co-morbidity with a life expectancy less than 6 months.
• •11. Co-morbidity expected to lower compliance.
• •12. Diagnosed kidney disease
• •13. Individuals sensitive to any of the study medication components.
• •14. Subject having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study medication.
• •15. Known abuse of alcohol, drugs or pharmaceuticals.
• •16. Diagnosis of squamous epithelia carcinoma
• •17. Diagnoses of a serious psychiatric illness which may influence study participation.
• •1.\& 2. = Run-in period criteria 1. \& 2.
• •3\. Subject having to the discretion of the investigator clinically significant findings on vital signs or laboratory values.
• •4.-10. = Run-in period criteria 6., 7., 8., 11., 12., 13., \& 14