Assessment of Efficacy & Tolerance of Urgo 310 3166 Dressing in Local Venous or Mixed Leg Ulcers
Not Applicable
Completed
- Conditions
- Ulcers, Leg
- Interventions
- Device: Urgo 310 3166 dressing
- Registration Number
- NCT03126396
- Lead Sponsor
- Laboratoires URGO
- Brief Summary
Assessment of efficacy \& tolerance of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers.
- Detailed Description
Assessment of efficacy, tolerance and acceptability of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers: multicenter trial, conducted in France.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
- Male or female 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 between 3 and 20 cm2
- Ulcer duration between 3 and 18 months,
- Ulcer presenting a surface wound bed covered with 50% or more by granulation tissue
- Moderately or heavily exudative ulcers.
Exclusion Criteria
A. Clinical infection on the wound bed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Urgo 310 3166 dressing Urgo 310 3166 dressing Urgo 310 3166 dressing
- Primary Outcome Measures
Name Time Method Efficacy - % of Wound Area Regression (WAR at week 12 % of Wound Area Regression (WAR), as a measure of efficacy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
URGO
🇫🇷Chenôve, France