| Confirmatory data from EU study supports Apligraf for the treatment of neuropathic diabetic foot ulcers. | |
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MedLine Citation:
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PMID: 20093548 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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INTRODUCTION: A study of 72 subjects conducted in the European Union and Australia assessed the safety and efficacy of Apligraf (Organogenesis, Inc, Canton, Massachusetts), a bilayered cell therapy composed of living keratinocytes and living fibroblasts in the treatment of non-infected, diabetic foot ulcers (DFU). The design and patient population of this study were similar to a 208-subject United States study (Veves et al., 2001), which led to FDA approval of Apligraf for the treatment of DFU. EU patient outcomes were compared and contrasted to established US-based patient outcome parameters. METHODS: Subjects with a non-infected neuropathic diabetic foot ulcer present for at least two weeks were enrolled in these prospective, multicenter, randomized, controlled, open-label studies that compared Apligraf used in conjunction with standard therapy (sharp debridement, standard wound care, and off-loading) against standard therapy alone. RESULTS: The design, conduct, and patient populations of the EU and US studies were comparable. Pooling of data was able to be performed because of the similarity and consistency of the two studies. Efficacy and safety results remained consistent across studies independent of mean ulcer duration that was significantly longer in the EU study (21 months, compared to 10 months in the US). Reported adverse events through 12 weeks were comparable across treatment groups in the two studies. Multiple efficacy measures consistently demonstrated superiority of Apligraf treatment over control treated groups in both studies. Combining the data from both studies, 55.2% (80/145) of Apligraf subjects had complete would closure by 12 weeks, compared to 34.3% (46/134) of Control subjects (P = 0.0005; Fisher's exact test), and Apligraf subjects had a significantly shorter time to complete wound closure (P = 0.0004; log-rank test). CONCLUSIONS: Both the EU and US studies exhibited superior efficacy and comparable safety for subjects treated with Apligraf compared to control treated subjects. The similar outcomes of the two studies provide robust, consistent evidence of the benefit of Apligraf in treating geographically disparate DFU patient populations. |
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Authors:
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John S Steinberg; Michael Edmonds; David P Hurley; William N King |
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Publication Detail:
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Type: Comparative Study; Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of the American Podiatric Medical Association Volume: 100 ISSN: 1930-8264 ISO Abbreviation: J Am Podiatr Med Assoc Publication Date: 2010 Jan-Feb |
Date Detail:
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Created Date: 2010-01-22 Completed Date: 2010-04-06 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8501423 Medline TA: J Am Podiatr Med Assoc Country: United States |
Other Details:
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Languages: eng Pagination: 73-7 Citation Subset: IM |
Affiliation:
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Georgetown University Hospital, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Collagen
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therapeutic use* Diabetic Foot / therapy* European Union Humans Multicenter Studies as Topic Prospective Studies Randomized Controlled Trials as Topic Skin, Artificial* United States |
| Chemical | |
Reg. No./Substance:
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0/Apligraf; 9007-34-5/Collagen |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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