Efficacy and safety of K-Two® versus Actico® compression system in the management of venous leg ulcers: a pilot study

Not Applicable

Completed

• Conditions: Venous leg ulceration; Circulatory System; Varicose veins of lower extremities

• Registration Number: ISRCTN47210331
• Lead Sponsor: aboratoires Urgo (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-26
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 232

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete ulcer closure (100% re-epithelialisation) at 12 weeks at the latest.