Clinical Trial: Biatain Ag vs Biatain in the Treament of Leg Ulcers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Assessment of Biatain Ag Dressings Compared to Biatain Dressings in the Treatment of Leg Ulcers
Brief Summary: the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy
Detailed Summary:
Sponsor: Coloplast A/S
Current Primary Outcome: relative variation in the area of the leg measured by planimetry at week 6 compared to the area at inclusion [ Time Frame: Day 0, 28, 42,70 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- relative reduction of the area of the leg ulcer at 10 weeks [ Time Frame: day 0, D28, D42, D70 ]
- Adverse events [ Time Frame: continuously ]
Original Secondary Outcome: Same as current
Information By: Coloplast A/S
Dates:
Date Received: December 11, 2008
Date Started: December 2008
Date Completion:
Last Updated: June 2, 2010
Last Verified: June 2010
