Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

A Randomised, Controlled and Double-blind Clinical Investigation on the Effectiveness and Safety of a Foam Dressing Biatain Ibu Non-adhesive vs. Biatain Non-adhesive, in Painful Chronic Venous Leg Ulcers

The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.

Inclusion Criteria:

• >= 18 years of age
• Chronic venous leg ulcer on the lower leg
• Ulcer duration >= 8 weeks
• Pain intensity in study ulcer at least 4 on an 11-point numerical box scale (NBS): 0= no pain, 10= worst possible pain
• Exudate level moderate to high
• Ulcer size min 1.6 cm and max 11 cm in any direction
• Ankle/brachial index >= 0.8
• Treated with moist wound healing during the past 2 weeks prior to inclusion
• Adequate compression therapy during the past 2 weeks prior to inclusion
• The patient is cognitive capable of evaluating his/her pain relief and pain intensity
• The patient is able to understand the treatment and is willing to comply with the treatment regimen.
• The patient is able to complete the patient diary
• The patient is willing and able to give written informed consent

Exclusion Criteria:

• Painful ulcers that have been treatment resistant to analgesics for the past 6 months or more
• Pregnant or lactating women
• Known and verified hypersensitivity to any content of the products used in this investigation
• Local infection (bacterial imbalanced wound) in the study ulcer
• Clinical infection in the study ulcer
• Diseases: Vasculitis, erysipelas and cellulitis of the peri-ulcer skin
• The investigator considers the patient not eligible
• Diseases and conditions where ibuprofen or other analgesics are contraindicated (including known hypersensitivity to Aspirin (acetylsalicylic acid) or other analgesics, especially associated with a history of asthma, rhinitis or urticaria)
• Diabetes
• Use of per need medication for the past 3 days
• Concomitant treatment with systemic antibiotics other than nitrofurantoin
• Concomitant treatment with systemic corticosteroids (more than 10 mg/day prednisolon or equivalent) or other immunosuppressants within 1 month prior to inclusion
• Concomitant treatment with cancer chemotherapeutics
• Concomitant participation in other studies
• Previous participation in this study