NCT01449422

Clinical Trial to Evaluate the Efficacy, Tolerance and Acceptability of URGO Dressing vs a Hydrofibre in the Local Management of Venous or Predominantly Venous Mixed Leg Ulcers.

Evaluation Of The Efficacy, Tolerance And Acceptability Of URGO Dressing 310 3082 Versus A Hydrofibre Dressing In The Local Management Of Venous Or Predominantly Venous Mixed Leg Ulcers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Laboratoires URGO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.

Conditions

• Varicose Ulcer

Interventions

Type	Name	Description
DEVICE	Dressing	the dressing should be changed on average every 1 to 2 days, then as often as required (up to 7 days) depending on the exudate volume and the clinical condition of the wound (evaluated by the investigating doctor).
DEVICE	Dressing	the hydrofibre dressing should be changed when it is saturated, or depending on the clinical appreciation of the situation. The dressing can remain in place for up to 7 days.

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-01-01
• First posted: 2011-10-10
• Last updated: 2013-03-29

Locations

1 site across 1 country: France