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DOI10.1186/1745-6215-14-8
Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial
Lev-Tov, Hadar1,2; Li, Chin-Shang3; Dahle, Sara1,2; Isseroff, Roslyn Rivkah1,2
通讯作者Dahle, Sara
来源期刊TRIALS
ISSN1745-6215
出版年2013
卷号14
英文摘要

Background: Diabetic foot ulcers (DFUs) represent a significant source of morbidity and an enormous financial burden. Standard care for DFUs involves systemic glucose control, ensuring adequate perfusion, debridement of nonviable tissue, off-loading, control of infection, local wound care and patient education, all administered by a multidisciplinary team. Unfortunately, even with the best standard of care (SOC) available, only 24% or 30% of DFUs will heal at weeks 12 or 20, respectively.


The extracellular matrix (ECM) in DFUs is abnormal and its impairment has been proposed as a key target for new therapeutic devices. These devices intend to replace the aberrant ECM by implanting a matrix, either devoid of cells or enhanced with fibroblasts, keratinocytes or both as well as various growth factors. These new bioengineered skin substitutes are proposed to encourage angiogenesis and in-growth of new tissue, and to utilize living cells to generate cytokines needed for wound repair.


To date, the efficacy of bioengineered ECM containing live cellular elements for improving healing above that of a SOC control group has not been compared with the efficacy of an ECM devoid of cells relative to the same SOC. Our hypothesis is that there is no difference in the improved healing effected by either of these two product types relative to SOC.


Methods/Design: To test this hypothesis we propose a randomized, single-blind, clinical trial with three arms: SOC, SOC plus Dermagraft (R) (bioengineered ECM containing living fibroblasts) and SOC plus Oasis (R) (ECM devoid of living cells) in patients with nonhealing DFUs. The primary outcome is the percentage of subjects that achieved complete wound closure by week 12.


Discussion: If our hypothesis is correct, then immense cost savings could be realized by using the orders-of-magnitude less expensive acellular ECM device without compromising patient health outcomes. The article describes the protocol proposed to test our hypothesis.


英文关键词Diabetic foot ulcer Chronic wounds Nonhealing wounds Oasis Dermagraft Wound matrix
类型Article
语种英语
国家USA
收录类别SCI-E
WOS记录号WOS:000314113800001
WOS关键词PRACTICAL GUIDELINES ; MANAGEMENT ; WOUNDS ; PREVENTION ; DISEASE
WOS类目Medicine, Research & Experimental
WOS研究方向Research & Experimental Medicine
来源机构University of California, Davis
资源类型期刊论文
条目标识符http://119.78.100.177/qdio/handle/2XILL650/180130
作者单位1.No Calif Healthcare Syst, Vet Affairs Med Ctr, Mather, CA 95655 USA;
2.Univ Calif Davis, Dept Dermatol, Sacramento, CA 95816 USA;
3.Univ Calif Davis, Dept Publ Hlth Sci, Div Biostat, Davis, CA 95616 USA
推荐引用方式
GB/T 7714
Lev-Tov, Hadar,Li, Chin-Shang,Dahle, Sara,et al. Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial[J]. University of California, Davis,2013,14.
APA Lev-Tov, Hadar,Li, Chin-Shang,Dahle, Sara,&Isseroff, Roslyn Rivkah.(2013).Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial.TRIALS,14.
MLA Lev-Tov, Hadar,et al."Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial".TRIALS 14(2013).
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