Safety and Efficacy Study of ICXP007 With Compression Bandaging for the Treatment of Non-Infected Venous Leg Ulcers
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|ClinicalTrials.gov Identifier: NCT00232973|
Recruitment Status : Unknown
Verified February 2008 by Intercytex.
Recruitment status was: Recruiting
First Posted : October 5, 2005
Last Update Posted : February 5, 2008
|Condition or disease||Intervention/treatment||Phase|
|Leg Ulcer||Drug: ICXP007||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||396 participants|
|Intervention Model:||Parallel Assignment|
|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 Treatment of Non-Infected Skin Leg Ulcers, Due to Venous-Insufficiency|
|Study Start Date :||July 2005|
- Incidence of 100% closure (epithelialized) at any time during the initial 12 weeks of the treatment period. [ Time Frame: 12 weeks ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232973
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