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Sponsored by: |
Intercytex |
Information provided by: | Intercytex |
ClinicalTrials.gov Identifier: | NCT00232973 |
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.
Condition | Intervention | Phase |
Leg Ulcer |
Drug: ICXP007 |
Phase III |
MedlinePlus related topics: | Leg Injuries and Disorders |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 396 |
Study Start Date: | July 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 58 Study Locations |
Intercytex |
Responsible Party: | Intercytex |
Study ID Numbers: | 02-VLU-003 |
First Received: | October 4, 2005 |
Last Updated: | February 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00232973 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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