The objective of this open label extension study (extension to study DK143WS) is to evaluate the safety of Biatain Ibu during 6 -12 weeks of exposure and during a 40 - 46 weeks safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.
N/A - since intervention is "local best practice"
Aarhus Universitetshospital
Aarhus, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Odense Universitets Hospital
Odense, Denmark
Georg-August-Universität Göttingen
Göttingen, Germany
Hospital de Fuenlabrada
Adverse events
Time frame: Week 1, 6, 20, 33, 46
Clinical occurrences
Time frame: Week 1, 6, 20, 33, 46
Ulcer area reduction
Time frame: Week 1, 6, 20, 33, 46
Ulcer status
Time frame: Week 1, 6, 20, 33, 46
Skin condition at healed ulcer location
Time frame: Week 1, 6, 20, 33, 46
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Fuenlabrada, Spain