Ulcers, Leg
Conditions
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.
Interventions
DEVICEUrgo 310 3166 dressing
Experimental: Urgo 310 3166 dressing
Sponsors
Laboratoires URGO
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female over 18 years old who has provided his/her written informed consent 2. Patient who can be monitored by the same investigation team throughout the whole duration of the study 3. Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing 4. Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3 5. Ulcer area between 3 and 20 cm2 6. Ulcer duration between 3 and 18 months, 7. Ulcer presenting a surface wound bed covered with 50% or more by granulation tissue 8. Moderately or heavily exudative ulcers.
Exclusion criteria
A. Clinical infection on the wound bed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - % of Wound Area Regression (WAR | at week 12 | % of Wound Area Regression (WAR), as a measure of efficacy |
Countries
France
Outcome results
None listed