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.
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Varicose Ulcer
Lead sponsor: Laboratoires URGO
Sponsor class: INDUSTRY
First posted: 2011-10-10
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.


Eligibility criteria: 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

Primary outcomes:
measure: The efficacy of dressings under trial will be judged on the evolution of wound surface area after six weeks of treatment.
timeFrame: Week 1, 2, 4 and 6
Secondary outcomes:
measure: 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.
timeFrame: Week 1, 2, 4 and 6
measure: 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
timeFrame: Week 1, 2, 4 and 6
measure: 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)
timeFrame: Week 1, 2, 4 and 6
measure: Comparison between the 2 groups of the percentage of wound care associated with manual debridement
timeFrame: Week 1, 2, 4 and 6
measure: 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
timeFrame: Week 1, 2, 4 and 6
measure: Comparison between the 2 groups of the percentage of the participants number with Adverse Events
timeFrame: Week 1, 2, 4 and 6
measure: Comparison between the 2 groups of the mean number of dressing changes per week.
timeFrame: Week 1, 2, 4 and 6
measure: Comparison between the 2 groups of the easiness application and removal
timeFrame: Week 1, 2, 4 and 6
measure: Comparison between the 2 groups of the percentage of good or very good conformability
timeFrame: Week 1, 2, 4 and 6
measure: Comparison between the 2 groups of the mean value for overall performance score
timeFrame: Week 1, 2, 4 and 6
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Rothschild
Study officials:
References: