Clinical Trial: Safety and Efficacy Study of ICXP007 With Compression Bandaging for the Treatment of Non-Infected Venous Leg Ulcers
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Prospective, Multi-Centre, Double Blind, Randomized, Placebo Controlled Trial to Evaluate the Safety and Efficacy of ICXP007 in a Phase III Trial With Four-Layer Therapeutic Compression, for the Tre
Brief Summary: The main purpose of the study is to compare treatment of non-infected venous leg ulcers using ICXP007 combined with four-layer compression bandaging, placebo combined with four-layer compression bandaging and four-layer compression bandaging alone.
Detailed Summary:
Sponsor: Intercytex
Current Primary Outcome: Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period. [ Time Frame: 12 weeks ]
Original Primary Outcome: Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period.
Current Secondary Outcome:
- Overall rate of wound area reduction during treatment.
- Time to first closure.
- Incidence of closure at 16, 20 and 24 weeks.
- Incidence of reopening at up to 16, 20 and 24 weeks.
- Incidence of re-closure at 16, 20 and 24 weeks.
- Qualitative levels of wound pain.
- Percentage of Day 0 wound surface area.
- Percentage reduction in wound surface area from previous visit.
- Percentage reduction in wound surface area from Day 0.
- Appearance of new ulcer in the target wound area post closure.
Original Secondary Outcome: Same as current
Information By: Intercytex
Dates:
Date Received: October 4, 2005
Date Started: July 2005
Date Completion:
Last Updated: February 4, 2008
Last Verified: February 2008
