- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01449422
Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers.
Evaluation Of The Efficacy, Tolerance And Acceptability Of URGO Dressing 310 3082 Versus A Hydrofibre Dressing In The Local Management Of Venous Or Predominantly Venous Mixed Leg Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75012
- Hôpital Rothschild
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 duration of the study
- Patient who agrees to wear effective venous compression every day, associated with the trial dressing
- Leg ulcer with a distal Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3
- Ulcer with a minimum area of 3 cm2 and a maximum area of 30 cm2
- Ulcer duration between 3 and 36 months
- Ulcer where the surface area is 70% or more covered by fibrinous tissue
- Ulcer at least 3 cm away from any other lesion
- Ulcer moderately or strongly exudative justifying the use of an absorbent dressing
Exclusion Criteria:
- Female patient of child-bearing potential who has no effective means of contraception
- Patient who is pregnant or breastfeeding
- Patient taking part in another therapeutic trial
- Patient with hypersensitivity to one of the components of the trial dressing or a known allergy to carboxymethylcellulose (hydrocolloid)
- Patient with a serious general pathological condition who, it may be feared, might discontinue participation in the trial before the six weeks of treatment
- Patient with an evolving neoplastic condition, treated by radiotherapy, chemotherapy or hormone therapy
- Patient with a systemic infection not controlled by suitable antibiotic treatment
- Patient who, during the 3 months before inclusion, presented a deep vein thrombosis
- Ulcer where its surface is totally or partially covered by black necrotic plaque
- Ulcer which is clinically infected
- Ulcer requiring surgical treatment or for which surgery is programmed during the six weeks following inclusion
- Malignant ulcer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aquacel
|
the dressing should be changed on average every 1 to 2 days, then as often as required (up to 7 days) depending on the exudate volume and the clinical condition of the wound (evaluated by the investigating doctor).
the hydrofibre dressing should be changed when it is saturated, or depending on the clinical appreciation of the situation.
The dressing can remain in place for up to 7 days.
|
Experimental: URGO 310 3082
|
the dressing should be changed on average every 1 to 2 days, then as often as required (up to 7 days) depending on the exudate volume and the clinical condition of the wound (evaluated by the investigating doctor).
the hydrofibre dressing should be changed when it is saturated, or depending on the clinical appreciation of the situation.
The dressing can remain in place for up to 7 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The efficacy of dressings under trial will be judged on the evolution of wound surface area after six weeks of treatment.
Time Frame: Week 1, 2, 4 and 6
|
The main evaluation criterion is the relative planimetric regression of the wound surface area, calculated according to the following formula, from centralised planimetric measurements: Regression of the area (%) = [(ST0-STlast)/ST0] x 100 ST0: Surface area of the lesion measured on the day of inclusion STlast: Surface area of the lesion at the last planimetric evaluation available |
Week 1, 2, 4 and 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison between the two devices of percentage of lesions in which the evolution is positive (defined by a relative regression at least 40% of wound surface) after monitoring for 6 weeks.
Time Frame: Week 1, 2, 4 and 6
|
Week 1, 2, 4 and 6
|
|
Comparison between the two groups of percentage of debrided lesions (defined by a lesion with more than 70% of its surface covered by granulation tissue of a "red colour" on the colorimetric scale), at the last available evaluation
Time Frame: Week 1, 2, 4 and 6
|
Week 1, 2, 4 and 6
|
|
Comparison between the two strategies of percentage of patients in whom at least one problem of pain was detected during care (VAS score at the end of care > 30 mm)
Time Frame: Week 1, 2, 4 and 6
|
Week 1, 2, 4 and 6
|
|
Comparison between the 2 groups of the percentage of wound care associated with manual debridement
Time Frame: Week 1, 2, 4 and 6
|
Week 1, 2, 4 and 6
|
|
Comparison between the two groups of the evolution of the patients' quality of life between inclusion and the last available visit. This quality of life will be assessed using the EuroQol-5D™ questionnaire
Time Frame: Week 1, 2, 4 and 6
|
Week 1, 2, 4 and 6
|
|
Comparison between the 2 groups of the percentage of the participants number with Adverse Events
Time Frame: Week 1, 2, 4 and 6
|
Week 1, 2, 4 and 6
|
|
Comparison between the 2 groups of the mean number of dressing changes per week.
Time Frame: Week 1, 2, 4 and 6
|
Week 1, 2, 4 and 6
|
|
Comparison between the 2 groups of the easiness application and removal
Time Frame: Week 1, 2, 4 and 6
|
Week 1, 2, 4 and 6
|
|
Comparison between the 2 groups of the percentage of good or very good conformability
Time Frame: Week 1, 2, 4 and 6
|
Week 1, 2, 4 and 6
|
|
Comparison between the 2 groups of the mean value for overall performance score
Time Frame: Week 1, 2, 4 and 6
|
This score will be between 0 and 36
|
Week 1, 2, 4 and 6
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FI-11-02-310 3082
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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