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.