Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers

URGO Group

Status: Unknown

Conditions: Leg Ulcers

Treatments: Device: Aquacel Extra; Device: Urgo 3103166

Study type: Interventional

Funder types: Industry

Identifiers

NCT02583958

FI-14-06-310 3166

Details and patient eligibility

About

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.

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 whole duration of the study,
• Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing,
• Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3,
• Ulcer area > or equal to 5cm2,
• Ulcer duration > or equal to 6 months,
• Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,
• Moderately or heavily exudative ulcers.

Exclusion criteria

• Clinical infection on the wound bed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Device Urgo 3103166

Experimental group

Description:

Soft-adherent hydro-desloughing dressing

Treatment:

Device: Urgo 3103166

Device Aquacel Extra

Active Comparator group

Description:

Hydrofibre dressing

Treatment:

Device: Aquacel Extra