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Clinical Research
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Investigation of acellular regenerative tissue matrix for ulcer repair on full-thickness lower extremity ulcers David Yeager, DPM, Jon Oliverio, DPM, Dixon, IL Chronic full-thickness lower extremity ulcers are a significant problem for approximately 15% of the diabetic population. These difficult-to-treat ulcers result in >50,000 lower extremity amputations per year. The primary objective of this investigation was to assess the efficacy of an acellular human dermal matrix in a series of patients for the treatment of Wagner grade 1 and 2 lower extremity ulcers Twelve patients with Wagner grade 1 (n=6) or 2 (n=6) full-thickness, non-infected, non-ischemic lower extremity ulcers were treated in this study The acellular regenerative tissue matrix was applied to each wound following sharp debridement. Patients were off-loaded and required to return weekly for 12 weeks or until wound was considered healed Of the 11 patients that completed the study, all 11 (100%) demonstrated complete healing after only one application of the matrix,and 9 of 11 (81.8%) patients healed within 12 weeks. Mean time to healing for patients with Grade 1 ulcers was 4.7 weeks, and 8.0 weeks for grade 2. In the 12 week evaluation, grafted patients showed a mean reduction in wound depth and wound area by 81.5% and 92.3%, respectively In this analysis, the acellular regenerative tissue matrix demonstrated the ability to advance wound healing in complex diabetic foot ulcers, including deep ulcers involving the tendon, capsule, or bone. A possible advantage of this matrix is the rapid healing of complex wounds that may prevent infection and subsequent amputation. National Diabetes Fact Sheet: National Estimates on Diabetes. Department of Health and Human Services, 2004 Naughton G, Mansbridge J, Gentzkow G. A metabolically active human dermal replacement for the treatment of diabetic foot ulcers. Artif Organs. 1997;21(11):1203Ð1210 Wagner FW, Jr. The diabetic foot. Orthop. 1987;10(1):163Ð172 Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound classification system. The contribution of depth, infection, and ischemia to risk of amputation. Diabetes Care. 1998;21(5):855Ð859 Jeffcoate WJ, Macfarlane RM, Fletcher EM. The description and classification of diabetic foot lesions. Diabet Med. 1993;10(7):676Ð679 Brigido SA, Boc SF, Lopez RC. Effective management of major lower extremity wounds using an acellular regenerative tissue matrix: a pilot study. Orthop. 2004;27(1 suppl):S145ÐS149 Boc S, Lopez, RC, Brigido, SA. Accelerated healing of lower extremity wounds with GRAFTJACKET Matrix, a human acellular regenerative tissue matrix. J Am Podiatr Med Assoc. 2005; in press Martin BR, Sangalang M, Wu S, Armstrong DG. Outcomes of allogenic acellular matrix therapy in treatment of diabetic foot wounds: an initial experience. Int Wound J. 2005;2(2):161Ð165 Data on file at Wright. |
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