Status:
COMPLETED
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.
Lead Sponsor:
Laboratoires URGO
Conditions:
Varicose Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 manage...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT01449422
Start Date
May 1 2011
Last Update
March 29 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Rothschild
Paris, France, 75012