Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers
NCT02583958 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2015-10-22
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.
Conditions
- Leg Ulcers
Interventions
- DEVICE
-
Urgo 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).
- DEVICE
-
Aquacel Extra
Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.
Sponsors & Collaborators
-
Laboratoires URGO
lead INDUSTRY
Principal Investigators
-
Sylvie Meaume, MD · Hospital Rothschild - Paris - France
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-10-31
- Primary Completion
- 2017-01-31
- Completion
- 2017-06-30
Countries
- France
Study Locations
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