Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedOctober 22, 2015
October 1, 2015
2.3 years
October 12, 2015
October 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Relative regression of wound surface area
week 20
Secondary Outcomes (3)
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
Study Arms (2)
Device Urgo 3103166
EXPERIMENTALSoft-adherent hydro-desloughing dressing
Device Aquacel Extra
ACTIVE COMPARATORHydrofibre dressing
Interventions
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 hydrofibre dressing can be left in place up to 7 days, where clinically indicated.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Clinical infection on the wound bed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Rothschild
Paris, 75012, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvie Meaume, MD
Hospital Rothschild - Paris - France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2015
First Posted
October 22, 2015
Study Start
October 1, 2014
Primary Completion
January 1, 2017
Study Completion
June 1, 2017
Last Updated
October 22, 2015
Record last verified: 2015-10