ABSTRACT
AIMS: The intravenous application of the chlorite-based drug solution WF10 is known to improve wound healing in patients with diabetic foot syndrome. In this retrospective study, we addressed the question, which effects are caused by this drug in patients with diabetic foot ulcers on the hemoglobin A1c value. METHODS: Patients received five consecutive daily infusions of WF10. Three patients received a second cycle of WF10, and one patient a third cycle. RESULTS: On a group of twelve patients with diabetic foot syndrome, WF10 gradually reduced the HbA1c values from a high-risk range (9.1 ± 1.6% (76 ± 13 mmol/mol)) into a low-risk range in all patients but one. These values remain low over at least 8 to 12 weeks after the administration of WF10. This drug improved also considerably wound healing processes in eleven patients. CONCLUSIONS: The chlorite component of WF10 is known to inactivate efficiently free cytotoxic hemoglobin forms that might accumulate in peripheral blood after hemolysis and induces the removal of pre-damaged red blood cells from circulation. By these mechanisms WF10 diminished toxic effects of hemolysis, improved microcirculation and glucose consumption in affected tissues, and prevented, thus, below knee amputation.
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.