Clinical Trial: EASH Dressing on Chronic Venous Leg Ulcers

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

Official Title: A Prospective, Multi-centre, Non-comparative Study to Evaluate the Safety and Preliminary Performance of the EASH Dressing on Chronic Venous Leg Ulcers

Brief Summary: The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.

Detailed Summary:
Sponsor: ConvaTec Inc.

Current Primary Outcome: Safety [ Time Frame: All 8 weeks ]

Nature and frequency of adverse events.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ulcer Improvement (wound bed) [ Time Frame: Baseline, week 4 and week 8 ]
  • Ulcer Improvement (peri-ulcer) [ Time Frame: Baseline, week 4 and week 8 or final visit ]
  • Healing [ Time Frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit ]
    Reduction in ulcer area
  • Healing [ Time Frame: 8 weeks or final visit ]
    Number of subjects healed
  • Healing [ Time Frame: 8 weeks or final visit ]
    Time to healing
  • Ulcer pain [ Time Frame: Weekly for 4 weeks then biweekly for 4 weeks or final visit ]
  • Comfort [ Time Frame: Weekly for 4 weeks then biweekly for 4 weeks ]
  • Ease of use [ Time Frame: Weekly for 4 weeks then biweekly for 4 weeks ]


Original Secondary Outcome: Same as current

Information By: ConvaTec Inc.

Dates:
Date Received: December 20, 2011
Date Started: November 2011
Date Completion:
Last Updated: April 24, 2012
Last Verified: April 2012