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 ]
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