NCT00628004 - Safety Evaluation of Biatain Ibu in Painful Chronic Venous Leg Ulcers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

July 31, 2009

Study Completion Date

February 28, 2010

Conditions

Leg Ulcers

Interventions

DEVICE

Biatain Ibu

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.

DEVICE

Local best practice

"N/A - since intervention is local best practice"

Trial Locations (5)

2400

Bispebjerg Hospital, Copenhagen

5000

Odense Universitets Hospital, Odense

8000

Aarhus Universitetshospital, Aarhus

28942

Hospital de Fuenlabrada, Fuenlabrada

37075

Georg-August-Universität Göttingen, Göttingen