NCT00627094

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Leg Ulcers

Interventions

Type	Name	Description
DEVICE	Biatain	A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.
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.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-02-29
• Last updated: 2017-09-15
• Results posted: 2017-02-07

Locations

13 sites across 4 countries: Denmark, France, Germany, Spain