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

To study clinical outcomes and safety of WF I 0 as an adjunct to standard treatment for diabetic foot ulcers (DFU) and to determine the optimal number of WF I 0 cycles that should be administered. A prospective, open-label study of WF I 0 adjunct to standard treatment for severe DFU but salvageable foot was carried out between July 2009 and June 20 I 0. 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]). From a total of 129 patients, 21 ( 16%) presented with neuropathic ulcers, 49 (38%) with ischaemic ulcers and 59 (46%) with severely infected ulcers.AII 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 (I I%), but no major amputation was required. Twenty seven patients (21 %) had transient reduction of haematocrit after WF I 0 therapy. One hundred and one patients (78 %) received only I cycle of WF I 0. WF I 0 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 WF I 0, transient reduction of haematocrit, was observed in 21% of patients. Most patients required only one cycle of WF I 0.