Leg Ulcers
Conditions
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.
Interventions
DEVICEUrgo 3103166
URGO 310 3166 dressing should be changed as often as required (let to the Investigator's convenience). The dressing change frequency is based on the exudate level and the clinical progress of the wound (up to 7 days).
DEVICEAquacel Extra
Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.
Sponsors
Laboratoires URGO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative regression of wound surface area | week 20 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of debrided wounds | at each clinical evaluation up to 20 weeks |
| Occurrence of adverse events as assessed by the investigator according to a classification MedDRA | between inclusion and week 20 |
| Patient's Quality of Life | at inclusion visit and at week 20 or at the end of study treatment |
Countries
France
Contacts
Primary ContactSylvie Meaume, MD
Outcome results
None listed