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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.

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ClinicalTrials.gov Identifier: NCT01449422
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
Laboratoires URGO

Tracking Information
First Submitted Date  ICMJE October 3, 2011
First Posted Date  ICMJE October 10, 2011
Last Update Posted Date March 29, 2013
Study Start Date  ICMJE May 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01449422 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2013)
  • 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 ]
  • 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 ]
  • 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 ]
  • Comparison between the 2 groups of the percentage of wound care associated with manual debridement [ Time Frame: 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 ]
  • Comparison between the 2 groups of the percentage of the participants number with Adverse Events [ Time Frame: 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 ]
  • Comparison between the 2 groups of the easiness application and removal [ Time Frame: 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 ]
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2011)
  • 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.
  • 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
  • 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)
  • Comparison between the 2 groups of the percentage of wound care associated with manual debridement
  • 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
  • Comparison between the 2 groups of the percentage of the participants number with Adverse Events
  • Comparison between the 2 groups of the mean number of dressing changes per week.
  • Comparison between the 2 groups of the easiness application and removal
  • Comparison between the 2 groups of the percentage of good or very good conformability
  • Comparison between the 2 groups of the mean value for overall performance score
    This score will be between 0 and 36
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Varicose Ulcer
Intervention  ICMJE
  • Device: Dressing
    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).
  • Device: Dressing
    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.
Study Arms  ICMJE
  • Experimental: URGO 310 3082
    Intervention: Device: Dressing
  • Active Comparator: Aquacel
    Intervention: Device: Dressing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2013)
159
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01449422
Other Study ID Numbers  ICMJE FI-11-02-310 3082
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laboratoires URGO
Study Sponsor  ICMJE Laboratoires URGO
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Laboratoires URGO
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP