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

Ulcers, Leg Clinical Trial

— CASSIOPEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126396
• Other study ID #: F-17-02-310 3166
• Status: Completed
• Phase: N/A
• Start date: May 11, 2017
• Est. completion date: July 16, 2018

Study information

• Verified date: December 2019
• Source: Laboratoires URGO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 16, 2018
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Ulcers, Leg

Intervention

Device:
• Urgo 310 3166 dressing
Experimental: Urgo 310 3166 dressing

Locations

Country	Name	City	State
France	URGO	Chenôve

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires URGO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - % of Wound Area Regression (WAR	% of Wound Area Regression (WAR), as a measure of efficacy	at week 12