Assessment of Efficacy & Tolerance of Urgo 310 3166 Dressing in Local Venous or Mixed Leg Ulcers (CASSIOPEE)

URGO Group

Status: Completed

Conditions: Ulcers, Leg

Treatments: Device: Urgo 310 3166 dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT03126396

F-17-02-310 3166

Details and patient eligibility

About

Assessment of efficacy & tolerance of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers.

Full description

Assessment of efficacy, tolerance and acceptability of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers: multicenter trial, conducted in France.

Enrollment: 51 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female over 18 years old who has provided his/her written informed consent
2. Patient who can be monitored by the same investigation team throughout the whole duration of the study
3. Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing
4. Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3
5. Ulcer area between 3 and 20 cm2
6. Ulcer duration between 3 and 18 months,
7. Ulcer presenting a surface wound bed covered with 50% or more by granulation tissue
8. Moderately or heavily exudative ulcers.

Exclusion criteria

A. Clinical infection on the wound bed.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Urgo 310 3166 dressing

Experimental group

Description:

Urgo 310 3166 dressing

Treatment:

Device: Urgo 310 3166 dressing