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.

NCT ID: NCT01449422

Last Updated: 2013-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31

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.

Conditions

Varicose Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

URGO 310 3082

Group Type: EXPERIMENTAL

Dressing

Intervention Type: DEVICE

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).

Aquacel

Group Type: ACTIVE_COMPARATOR

Dressing

Intervention Type: DEVICE

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires URGO

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Rothschild

Paris, , France

Countries

France

Other Identifiers

FI-11-02-310 3082

Identifier Type: -

Identifier Source: org_study_id