Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers
Not Applicable
- Conditions
- Leg Ulcers
- Registration Number
- NCT02583958
- Lead Sponsor
- Laboratoires URGO
- 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 Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patient over 18 years old who has provided his/her written informed consent,
- Patient who can be monitored by the same investigation team throughout the whole duration of the study,
- Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing,
- Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3,
- Ulcer area > or equal to 5cm2,
- Ulcer duration > or equal to 6 months,
- Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,
- Moderately or heavily exudative ulcers.
Exclusion Criteria
- Clinical infection on the wound bed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Relative regression of wound surface area week 20
- Secondary Outcome Measures
Name Time Method Percentage of debrided wounds at each clinical evaluation up to 20 weeks Patient's Quality of Life at inclusion visit and at week 20 or at the end of study treatment Occurrence of adverse events as assessed by the investigator according to a classification MedDRA between inclusion and week 20
Trial Locations
- Locations (1)
Hospital Rothschild
🇫🇷Paris, France
Hospital Rothschild🇫🇷Paris, FranceSylvie Meaume, MDContact