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.

URGO Group

Status and phase

Completed

Phase 4

Conditions

Varicose Ulcer

Treatments

Device: Dressing

Study type

Interventional

Funder types

Industry

Identifiers

NCT01449422

FI-11-02-310 3082

Details and patient eligibility

About

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.

Enrollment

159 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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