Clinical Trial: Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Assessment of Efficacy and Safety for a New Wound Dressing URGO 310 3166 in the Local Treatment of Venous or Mixed Leg Ulcers: A European, Randomised Clinical Trial
Brief Summary: Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.
Detailed Summary:
Sponsor: Laboratoires URGO
Current Primary Outcome: Relative regression of wound surface area [ Time Frame: week 20 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of debrided wounds [ Time Frame: at each clinical evaluation up to 20 weeks ]
- Occurrence of adverse events as assessed by the investigator according to a classification MedDRA [ Time Frame: between inclusion and week 20 ]
- Patient's Quality of Life [ Time Frame: at inclusion visit and at week 20 or at the end of study treatment ]
Original Secondary Outcome: Same as current
Information By: Laboratoires URGO
Dates:
Date Received: October 12, 2015
Date Started: October 2014
Date Completion: June 2017
Last Updated: October 20, 2015
Last Verified: October 2015
