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
Not Applicable
Recruiting
- Conditions
- leg ulcers
- Registration Number
- DRKS00009329
- Lead Sponsor
- aboratoires URGO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 220
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 Superior or equal to 5 cm2,
Ulcer duration Superior or equal to 6 months,
Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,
Moderately or heavly exudative ulcers.
Exclusion Criteria
Clinical infection on the wound bed
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the percentage of lesions which reached a relative regression of surface after 20 weeks of treatment will be compared between 2 groups. Planimetric records will be performed every month until week 20 to mesure the surface of the wound.
- Secondary Outcome Measures
Name Time Method Percentage of debrided wounds at each clinical evaluation (defined by a lesion with more than 70% of its surface covered by granulation tissue),<br>Tolerance,<br>Evolution of the patient's Quality of Life between inclusion and Week 20 or at the end of trial treatment (EuroQol 5D-5L™)<br><br>