Clinical Trial: Physiotulle vs Urgotul in the Treatment of Leg Ulcer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Assessment of Physiotulle Dressing Compared to Urgotul Dressing in the Treatment of Leg Ulcer

Brief Summary: The aim of this study is to assess the pain at removal of Physiotulle dressing in comparison with that of Urgotul dressing in patients presenting a venous (or predominantly) venous leg ulcer.

Detailed Summary:
Sponsor: Coloplast A/S

Current Primary Outcome: pain at dressing removal [ Time Frame: 4 weeks ]

pain at dressing removal assessed by the patient immediately after dressing removal on a VAS scale


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Relative reduction of the area of the leg ulcer measured by planimetry at final point at week 4 compared to the area at inclusion [ Time Frame: 4weeks ]
  • Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 4 weeks ]


Original Secondary Outcome: Same as current

Information By: Coloplast A/S

Dates:
Date Received: October 27, 2010
Date Started: November 2009
Date Completion:
Last Updated: September 2, 2011
Last Verified: October 2010