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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratoires URGO
ClinicalTrials.gov Identifier:
NCT01449422
First received: October 3, 2011
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Varicose Ulcer
Device: Dressing
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Laboratoires URGO:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Comparison between the 2 groups of the percentage of wound care associated with manual debridement [ Time Frame: Week 1, 2, 4 and 6 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Comparison between the 2 groups of the percentage of the participants number with Adverse Events [ Time Frame: Week 1, 2, 4 and 6 ] [ Designated as safety issue: Yes ]
  • Comparison between the 2 groups of the mean number of dressing changes per week. [ Time Frame: Week 1, 2, 4 and 6 ] [ Designated as safety issue: No ]
  • Comparison between the 2 groups of the easiness application and removal [ Time Frame: Week 1, 2, 4 and 6 ] [ Designated as safety issue: No ]
  • Comparison between the 2 groups of the percentage of good or very good conformability [ Time Frame: Week 1, 2, 4 and 6 ] [ Designated as safety issue: No ]
  • Comparison between the 2 groups of the mean value for overall performance score [ Time Frame: Week 1, 2, 4 and 6 ] [ Designated as safety issue: No ]
    This score will be between 0 and 36


Enrollment: 159
Study Start Date: May 2011
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: URGO 310 3082 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).
Active Comparator: Aquacel 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449422

Locations
France
Hopital Rothschild
Paris, France, 75012
Sponsors and Collaborators
Laboratoires URGO
  More Information

No publications provided

Responsible Party: Laboratoires URGO
ClinicalTrials.gov Identifier: NCT01449422     History of Changes
Other Study ID Numbers: FI-11-02-310 3082
Study First Received: October 3, 2011
Last Updated: March 28, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
Germany: Ethics Commission

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014