Effect of WF10 (Immunokine) on Diabetic Foot Ulcer Therapy: A Double-blind, Randomized, Placebo-controlled Trial

Abstract

This randomized controlled trial was undertaken to evaluate the effect of WF10 (Immunokine) as an adjunct to the standard treatment of diabetic foot ulcer. A total of 40 participants were randomized into 2 groups of 20. One group underwent standard therapy combined with infusions of WF10, and 1 underwent standard therapy combined with placebo. The wound severity scores, which vary with the severity of infection and inflammation, necrotic and granulation tissues, and wound depth and area, were assessed weekly for 9 weeks. Before treatment, the wound severity scores were not significantly different statistically between the 2 groups (13.7 ± 2.8 and 12.9 ± 3.2). After 9 weeks, the WF10 group had a statistically significant decreased wound severity score compared with that of the placebo group (1.8 ± 1.9 versus 4.4 ± 5.3, respectively, p < .05). Subgroup analyses comparing the WF10 and placebo groups showed statistically significant decreases of infection and inflammation (0.0 ± 0.0 versus 0.8 ± 0.9, respectively, p < .01), necrotic tissue (0.0 ± 0.0 versus 0.8 ± 1.1, respectively, p < .01), and an increase of the amount of granulation tissue (0.1 ± 0.3 versus 0.8 ± 1.2, respectively, p < .05). The wound depth and wound area also decreased more in the WF10 group; however, these decreases were not statistically significant. No severe adverse events were observed throughout the observation period. We concluded that the addition of WF10 to standard wound care statistically significantly reduced the wound severity score, infection and inflammation, and necrotic tissue and enhanced the formation of granulation tissue. © 2011 American College of Foot and Ankle Surgeons.