ISRCTN47210331
Completed
未知
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 sites232 target enrollmentJune 26, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- aboratoires Urgo (France)
- Enrollment
- 232
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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®)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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