Skip to main content
OpenTrials
Completed

NCT Number: NCT03126396

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ulcers, Leg Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

URGO

Chenôve, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female 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 between 3 and 20 cm2
  • Ulcer duration between 3 and 18 months,
  • Ulcer presenting a surface wound bed covered with 50% or more by granulation tissue
  • Moderately or heavily exudative ulcers.

Exclusion criteria

A. Clinical infection on the wound bed.

Treatment and study plan

Urgo 310 3166 dressing

Device

Experimental: Urgo 310 3166 dressing

Primary outcomes

  1. Efficacy - % of Wound Area Regression (WAR

    Time frame: at week 12

    % of Wound Area Regression (WAR), as a measure of efficacy

Sponsors and collaborators

Lead sponsor

Laboratoires URGO

Industry

Registry information

Official study title

Assessment of Efficacy, Tolerance and Acceptability of Urgo 310 3166 Dressing in the Treatment of Local Venous or Mixed Leg Ulcers

Acronym: CASSIOPEE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2017
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.