Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers
NCT ID: NCT02583958
Last Updated: 2015-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
INTERVENTIONAL
2014-10-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Device Urgo 3103166
Soft-adherent hydro-desloughing dressing
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
Hydrofibre dressing
Aquacel Extra
Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.
Interventions
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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).
Aquacel Extra
Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Laboratoires URGO
INDUSTRY
Responsible Party
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Principal Investigators
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Sylvie Meaume, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Rothschild - Paris - France
Locations
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Hospital Rothschild
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Sylvie Meaume, MD
Role: primary
Other Identifiers
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FI-14-06-310 3166
Identifier Type: -
Identifier Source: org_study_id
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