Wound Healing Institute, Aurora, Colorado, USA.
Wound Repair Regen. 1994 Oct;2(4):259-69. doi: 10.1046/j.1524-475X.1994.20406.x.
A multicenter, randomized, evaluator-blinded, placebo-controlled clinical study was conducted to evaluate the safety and effectiveness of glycyl-l-histidyl-l-lysine: copper complex (lamin Gel) in the treatment of diabetic neuropathic ulcers. All patients were enrolled in an aggressive standardized wound care protocol consisting of sharp debridement at study entry, daily application of a metered dose of drug, standardized pressure-relieving footwear, and patient education relating to diabetes control and activity modifications. Treatment with lamin Gel significantly increased the percentage of closure of plantar ulcers (98.5% median area percentage closure compared with 60.8% for vehicle; p < 0.05) and the proportion of patients healing 98% or better. The rate of closure was three times faster with lamin Gel treatment compared with standard care and vehicle. The enhancement of wound closure was more pronounced (median of 89.2% compared with -10.3% for vehicle; p < 0.01) in larger (greater than 100 mm(2) initial area at study entry) plantar ulcers caused by the failure of this size of ulcer to respond adequately to standardized wound care treatments in the absence of lamin Gel. Treatment must commence immediately after the initial wound debridement to obtain optimal enhancement of the ulcer closure. The incidence of ulcer infections was significantly lower (7% incidence compared with 34% for vehicle, p < 0.05) in the plantar ulcers treated immediately after debridement with the lamin Gel.
一项多中心、随机、评估者盲法、安慰剂对照的临床研究评估了甘氨酰-L-组氨酰-L-赖氨酰铜复合物（lamin Gel）治疗糖尿病性神经溃疡的安全性和有效性。所有患者均纳入一项强化标准化伤口护理方案，该方案包括在研究入组时进行锐性清创、每日应用计量药物、标准化减压鞋和与糖尿病控制及活动调整相关的患者教育。与安慰剂相比，lamin Gel 治疗显著增加了足底溃疡的闭合百分比（中位数面积百分比闭合率为 98.5%，而安慰剂为 60.8%；p<0.05）和 98%以上愈合的患者比例。与标准护理和安慰剂相比，lamin Gel 治疗的闭合速度快了三倍。与安慰剂相比（中位数为-10.3%），在因标准化伤口护理治疗对大于 100mm2 的溃疡（研究入组时初始面积大于 100mm2）无效而导致的更大的足底溃疡中，伤口闭合的增强更为明显（中位数为 89.2%；p<0.01）。为了获得溃疡闭合的最佳增强，治疗必须在初始伤口清创后立即开始。与安慰剂相比，在立即用 lamin Gel 清创后治疗的足底溃疡中，溃疡感染的发生率显著降低（分别为 7%和 34%；p<0.05）。
