Topical administration of a connexin43-based peptide augments healing of chronic neuropathic diabetic foot ulcers: A multicenter, randomized trial.
Topical administration of a connexin43-based peptide augments healing of chronic neuropathic diabetic foot ulcers: A multicenter, randomized trial.
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DOI：
10.1111/wrr.12275
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发表时间：
2015-03
期刊：
影响因子：
--
通讯作者：
Ghatnekar GS
中科院分区：
文献类型：
--
作者：
Grek CL;Prasad GM;Viswanathan V;Armstrong DG;Gourdie RG;Ghatnekar GS
不愈合的神经性足部溃疡仍然是糖尿病患者的一个重要问题。缝隙连接蛋白43（Cx43）在皮肤伤口愈合中起作用，并且靶向Cx43信号传导加速伤口再上皮化。在一项前瞻性、随机、多中心临床试验中，我们评估了Cx43 C末端的肽模拟物ACT 1在纳入标准护理方案时加速慢性糖尿病足溃疡（DFU）愈合的疗效和安全性。DFU持续时间至少4周的成人随机接受标准治疗，局部应用或不应用ACT 1。主要结局是溃疡上皮再生的平均百分比，安全性变量包括治疗相关不良事件的发生率和ACT 1免疫原性的检测。ACT 1治疗与基线至12周平均溃疡面积百分比显著更大的降低相关（72.1% vs. 57.1%; p = 0.03）。对发生率和中位溃疡完全闭合时间的分析显示，ACT 1治疗与达到100%溃疡上皮再生的参与者百分比更高以及中位溃疡完全闭合时间缩短相关。没有报告与治疗相关的不良事件，ACT 1没有免疫原性。合并ACT 1的治疗方案可能是一种安全增强慢性DFU上皮再生的治疗策略。
Nonhealing neuropathic foot ulcers remain a significant problem in individuals with diabetes. The gap-junctional protein connexin43 (Cx43) has roles in dermal wound healing and targeting Cx43 signaling accelerates wound reepithelialization. In a prospective, randomized, multi-center clinical trial we evaluated the efficacy and safety of a peptide mimetic of the C-terminus of Cx43, ACT1, in accelerating the healing of chronic diabetic foot ulcers (DFUs) when incorporated into standard of care protocols. Adults with DFUs of at least four weeks duration were randomized to receive standard of care with or without topical application of ACT1. Primary outcome was mean percent ulcer reepithelialization and safety variables included incidence of treatment related adverse events and detection of ACT1 immunogenicity. ACT1 treatment was associated with a significantly greater reduction in mean percent ulcer area from baseline to 12 weeks (72.1% vs. 57.1%; p = 0.03). Analysis of incidence and median time-to-complete-ulcer closure revealed that ACT1 treatment was associated with a greater percentage of participants that reached 100% ulcer reepitheliazation and a reduced median time-to-complete-ulcer closure. No adverse events reported were treatment related, and ACT1 was not immunogenic. Treatment protocols that incorporate ACT1 may present a therapeutic strategy that safely augments the reepithelialization of chronic DFUs.
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影响因子：
5.3
作者：
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