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Sponsored by: |
Ethicon, Inc. |
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Information provided by: | Ethicon, Inc. |
ClinicalTrials.gov Identifier: | NCT00235209 |
This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on venous leg ulcers.
Condition | Intervention | Phase |
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Leg Ulcer |
Device: Collagen ORC Antimicrobial Matrix (CAM) |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | A Study to Evaluate the Clinical Effectiveness of a Collagen-ORC Antimicrobial Matrix in Venous Leg Ulcers |
Estimated Enrollment: | 48 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | December 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Foot and Ankle Institute of South Florida | |
South Miami, Florida, United States | |
Wound Care Center | |
Ft Lauderdale, Florida, United States | |
United States, Pennsylvania | |
Penn North Centers for Advanced Wound Care | |
Warren, Pennsylvania, United States |
Study Director: | James Hart, MD | Ethicon, Inc. |
Study ID Numbers: | 400-04-002 |
Study First Received: | October 6, 2005 |
Last Updated: | October 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00235209 |
Health Authority: | United States: Institutional Review Board |
Skin Diseases Ulcer Skin Ulcer Leg Ulcer |
Pathologic Processes |