CLEANER 310 3166 in the treatment of venous or mixed leg ulcers
Research type
Research Study
Full title
CLEANER - Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.
IRAS ID
168032
Contact name
Olivier Tacca
Contact email
Sponsor organisation
Laboratories URGO
Clinicaltrials.gov Identifier
SURG-3933, NIHR CRN
Duration of Study in the UK
1 years, 9 months, 29 days
Research summary
The main purpose of this trial is to demonstrate that the URGO 310 3166 dressing is more effective than the alternative therapeutic strategy using the Aquacel® Extra™ dressing in the local management of venous or predominantly venous mixed leg ulcers. This hypothesis will be assessed by comparison of the shrinkage of the wound surface area after 20 weeks of local treatment with the two dressings.
After 20 weeks of treatment, patients whose lesions have not healed can continue on to follow-up. The objective of the follow-up is to determine the percentage of complete closure of these ulcers for a further 20 weeks.
This is a prospective multicentre randomised controlled trial carried out in several countries: France, Germany, and United Kingdom. The trial will be performed in hospital departments or in community care sites. It will include 220 outpatients and/or hospitalised patients, randomised into two parallel groups, each of 110 patients (1:1 randomisation for the trial dressings). Patients will be aged 18 years old or over, and will have provided a written informed consent. The patients may be hospitalised and/or outpatients. Patients must agree to wear effective venous compression every day, associated with the trial dressing.
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/0140
Date of REC Opinion
30 Jan 2015
REC opinion
Further Information Favourable Opinion