Evaluation of the efficacy and the safety of the K-Two® versus Actico® compression systems in the management of venous leg ulcers: a randomised parallel group open label pilot study

aboratoires Urgo (France)0 个研究点目标入组 232 人开始时间: 2009年6月26日最近更新: 2016年10月17日

试验速览

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•1. Patients over 18 years old, either sex, who have provided his written informed consent
•2. Patient who can be followed by the same investigating team for the 12 weeks treatment period
•3. Patient who agrees to concord to the study/wear this type of multilayer compression system for at most one week
•4. Patient presenting an ankle circumference included between 18 to 32 cm
•5. Ulcer between 2 and 50 cm^2 in surface
•6. Ulcer duration between 1 and 24 months, for a new leg ulcer (not recurrent)
•7. Ulcer duration under 24 months, for a recurrent leg ulcer
•8. Venous or mixed leg ulcer (Ankle Brachial Pressure Index greater than 0.8 and less than 1.3 in both legs at inclusion)
•9. Ulcer at least 3 cm, from any other wound located on the same limb
•10. Leg ulcer treated by a contact layer as a primary dressing (Urgotul®)

•1. Patient participating in another clinical trial
•2. Female patient of childbearing age who does not have any mode of contraception and is able to become pregnant during the study period
•3. Patient with known hypersensitivity to one of the components of the tested compression systems
•4. Patient with known hypersensitivity to the interface primary dressing (Urgotul®)
•5. Patient presenting a neoplasic lesion treated by radiotherapy or chemotherapy or patients treated with immunosuppressive drugs or high-dose corticosteroids
•6. Patient who has undergone surgery directly related to his/her venous insufficiency in the 2 months prior to inclusion
•7. Patient with a history of deep or superficial vein thrombosis in the 3 months prior to inclusion
•8. Patient confined to bed
•9. Ulcer for which surgery is scheduled in the 12 weeks after inclusion
•10. Ulcer which is clinically infected
•11. Ulcer surface area totally (100% of surface) covered with dry fibrinous tissue (sloughy tissue) at inclusion or black necrotic plaque covering more than 10% of ulcer area
•12. Cancerous ulcer

发起方

aboratoires Urgo (France)