A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers

Exclusion Criteria

• •1. Does the subject have severe arterial occlusive disease?
• •2. Does the subject have decompensated heart insufficiency NYHA Class IV, ACC.AHA Stage D?
• •3. Does the subject have septic phlebitis?
• •4. Does the subject have severe deep vein thrombosis (phlegmasia cerulea dolens) and other conditions contraindicated according to established guidelines and local procedures?
• •5. Does the subject have known hypersensitivity to any of the component materials?
• •6. Does the subject have a suspected clinical infection of the ulcer or any other systemic infection (requiring antibiotics)?
• •7. Is the subject scheduled for surgery for the ulcer during the 12 weeks following inclusion?
• •8. Does the subject have a hospital stay planned for the 12 weeks following inclusion?
• •9. Does the subject have a suspected or confirmed cancerous ulceration?
• •10. Does the subject have severe peripheral sensitive neuropathy?
• •11. Is the subject participating in any other prospective study interfering with this study?
• •12. Does the subject have any medical condition which in the professional opinion of the investigator disqualifies the subject from enrollment into the study?
• •13. Does the subject have a history of noncompliance to therapies?