采用脱细胞真皮基质治疗深度暴露的复杂糖尿病足溃疡的前瞻性、多中心、单臂临床试验。
A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix.
机构信息
Shawn Cazzell, DPM, FAPWCA, FAPWH, is Chief Medical Officer, Limb Preservation Platform, Fresno, California. Peter M. Moyer, DPM, FACFAS, AAPWCA, is Podiatrist, Purvis Moyer Foot and Ankle Center, Rocky Mount, North Carolina. At LifeNet Health, Virginia Beach, Virginia, Brian Samsell, BS, is Scientific Writer; Kimberly Dorsch, BS, CCRP, CRCP, is Director of Global Clinical Affairs; Julie McLean, PhD, is Senior Manager of Scientific Affairs; and Mark A. Moore, PhD, is Global Senior Director of Scientific Affairs. Acknowledgments: The authors thank Collin Smith for data analysis support. This study was funded by LifeNet Health, a nonprofit organization that processes the studied acellular dermal matrix. Dr Cazzell and Dr Moyer were among the clinical trial investigators for this study and received research funding. Mr Samsell, Ms Dorsch, Dr McLean, and Dr Moore are employees of LifeNet Health. All patient outcomes were evaluated solely by the investigators to minimize potential for bias. The authors have disclosed no other financial relationships related to this article. Submitted January 3, 2019; accepted in revised form March 8, 2019; published online ahead of print, July 9, 2019.
出版信息
Adv Skin Wound Care. 2019 Sep;32(9):409-415. doi: 10.1097/01.ASW.0000569132.38449.c0.
OBJECTIVE
This prospective, multicenter study evaluated the efficacy and safety of an acellular dermal matrix allograft, DermACELL (D-ADM; LifeNet Health, Virginia Beach, Virginia), in the treatment of large, complex diabetic foot ulcers (DFUs) that probed to tendon or bone.
METHODS
Inclusion criteria were Wagner grade 3 or 4 DFUs between 4 weeks and 1 year in duration. All participants received one application of D-ADM at baseline and could receive one additional application if wound healing arrested. Ulcers were assessed weekly for 16 weeks using a laser measuring device.
RESULTS
Sixty-one participants were enrolled, with an average wound area of 29.0 cm; 59 of these ulcers showed exposed bone. The entire per-protocol population (n = 47) achieved 100% granulation. The mean time to 100% granulation was 4.0 weeks with an average of 1.2 applications of D-ADM. Mean percent wound area reduction was 80.3% at 16 weeks. Those DFUs 15 cm or smaller were substantially more likely to close than DFUs larger than 29 cm (P = .0008) over a 16-week duration. No complications were associated with the use of the studied matrix.
CONCLUSIONS
The D-ADM demonstrated the ability to rapidly reduce the size of large, complex DFUs with exposed bone. Some wounds did not completely heal by 16 weeks; however, the significant reduction in size suggests that these large, complex wounds may heal if given more time.
目的
本前瞻性、多中心研究评估了脱细胞真皮基质移植物 DermACELL（D-ADM；LifeNet Health，弗吉尼亚海滩，弗吉尼亚州）在治疗大、复杂的糖尿病足溃疡（DFU）中的疗效和安全性，这些溃疡探及肌腱或骨骼。
方法
纳入标准为 Wagner 分级 3 或 4 级的 DFU，病程在 4 周至 1 年之间。所有参与者在基线时接受一次 D-ADM 治疗，如果伤口愈合停滞，可以接受另外一次治疗。在 16 周内，使用激光测量设备每周评估一次溃疡。
结果
61 名参与者入组，平均伤口面积为 29.0cm²；其中 59 个溃疡显示有暴露的骨骼。整个符合方案人群（n=47）实现了 100%肉芽形成。达到 100%肉芽形成的平均时间为 4.0 周，平均使用 1.2 次 D-ADM。16 周时平均伤口面积减少 80.3%。在 16 周的时间内，15cm 或更小的 DFU 比大于 29cm 的 DFU 更有可能闭合（P=.0008）。使用研究中的基质没有出现任何并发症。
结论
D-ADM 迅速减少了大、复杂伴有骨骼暴露的 DFU 的大小。一些伤口在 16 周内没有完全愈合；然而，伤口大小的显著减少表明，如果给予更多时间，这些大、复杂的伤口可能会愈合。
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