Clinical outcomes of WF10 adjunct to standard treatment of diabetic foot ulcers

Abstract

Objective: To study clinical outcomes and safety of WF10 as an adjunct to standard treatment for diabetic foot ulcers (DFU) and to determine the optimal number of WF10 cycles that should be administered. Method: A prospective, open-label study of WF10 adjunct to standard treatment for severe DFU but salvageable foot was carried out between July 2009 and June 2010. Patients were classified into three groups, according to common clinical presentations: neuropathic ulcer, ischaemic ulcer and severely infected ulcer. Ulcer assessments were monitored using the wound severity score (WSS; range 0-16). The clinical outcomes at 24 weeks were defined as 'good' (ulcer achieved endpoint [WSS=0-1]), 'fair' (improved from baseline [WSS=2-4]) and 'poor' (not improved or worsened [WSS > 4]). Results: From a total of 129 patients, 21 (16%) presented with neuropathic ulcers, 49 (38%) with ischaemic ulcers and 59 (46%) with severely infected ulcers. All neuropathic ulcers achieved either a good or fair outcome, with 81% achieving a good outcome, as did 49% and 81% of ischaemic and severely infected ulcers, respectively. Minor amputations were necessary for 14 patients (11%), but no major amputation was required. Twenty seven patients (21%) had transient reduction of haematocrit after WF10 therapy. One hundred and one patients (78 %) received only 1 cycle of WF10. Conclusion: WF10 as an adjunct to standard DFU treatment showed good clinical outcomes in the neuropathic ulcer group and the severely infected ulcer group. A side effect of WF10, transient reduction of haematocrit, was observed in 21% of patients. Most patients required only one cycle of WF10. Declaration of interest: There were no external sources of funding for this study. The author has no conflicts of interest to declare.