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Oral Abstracts (Session 3 of 5)
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Moderator: Susan Dieter, RN, MS, CWCN, CWS (Presentation 34.4) A randomized, open-label, multicenter study to compare the safety and efficacy of bi-layered cell therapy versus standard therapy in the treatment of diabetic foot ulcers Michael Edmonds, MD; Alethea Foster, for the Apligraf Study Group, from the Diabetic Foot Clinic, King’s College Hospital, London, United Kingdom Abstract: A randomized, open-label, multicenter study compared the safety and efficacy of bi-layered cell therapy versus standard therapy in the treatment of diabetic foot ulcers. The bi-layered cell therapy* has been shown to facilitate healing of diabetic foot ulcers. The effectiveness and safety of the bi-layered cell therapy was assessed in a 12-week treatment of neuropathic diabetic foot ulcers. In 7 centers across Europe and 1 in Australia, 72 patients were randomly assigned to either bi-layered cell therapy (33 patients) or saline-moistened gauze (39 patients). All patients received standard treatment, which included surgical debridement and pressure offloading with an Aircast Walker. The bi-layered cell therapy was applied up to 3 times during the 12-week period, with applications at baseline and at weeks 4 and 8. Complete wound healing was assessed at 12 weeks. At the 12-week follow up, 51% of the bi-layered cell therapy-treated patients achieved complete wound healing compared with 26.3% in the control group (p=0.049, Fisher’s exact test). The average number of applications to achieve 100% closure was 1.8. The Kaplan-Meier median time to complete closure was 49 days for the bi-layered cell therapy and 45 days in the control group (NS). The rate of serious adverse events was similar between the 2 groups (15.2% and 12.8%). The bi-layered cell therapy combined debridement and pressure offloading was more effective in healing of neuropathic diabetic foot ulcers. * Apligraf® is a registered trademark of Organogenesis, Inc., Canton, Mass |
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