Publication

Abstract : Aim To test the hypothesis that fluconazole plus standard care is superior to the standard care for diabetic foot wounds infected with deep-seated fungal infections. Methods We carried out a randomized, controlled, open-label, parallel-arm study in 75 patients with both fungal and bacterial infections in deep tissues of diabetic foot wounds. Thirty-seven patients (control group) were given standard care (surgical debridement+culture-specific antibiotics+offloading+glycaemic control) and 38 patients (treatment group) were given fluconazole 150mg daily plus standard care. Wound surface area was measured every 2weeks until the endpoints (complete epithelialization or skin grafting) were met. Results By week4, the mean wound surface area reduced to 27.3 from 111.5cm2 in the treatment group, as opposed to 67.1 from 87.3cm2 in the control group. Subsequently, the mean wound surface areas were remarkably smaller in the treatment group compared with the control group, and statistically significant differences (P≤0.05) in mean wound surface area were observed between the treatment group and the control group at week6. However, no statistically significant (P≤0.47) difference in complete healing was observed between the treatment group and the control group, 20 vs. 24. The mean wound healing time for the treatment group was 7.3weeks, whereas for the control group it was 11.3weeks (P≤0.022). Similarly, the probability of wound healing in the treatment group was 50 vs. 20% in the control group at week10. Conclusions Fluconazole plus standard care was superior to standard care alone in accelerating wound reduction among patients with diabetes with deep-seated fungal infections in diabetic foot wounds. Those in the treatment group who did heal, healed more quickly (P≤0.022), but overall healing was not different. © 2012 Diabetes UK.