[abstract] HYPERBARIC OXYGEN THERAPY FOR DIABETIC LEG ULCERS - A DOUBLE-BLIND RANDOMISED-CONTROLLED TRIAL

Abstract

BACKGROUND: 14-24percent of diabetic patients with ischaemic leg ulcers will require an amputation. Despite the progress of medicine and much effort toward amputation prevention in the last decade, the incidence of lower limb amputation in such patients continues to rise. We aimed to evaluate the role of hyperbaric oxygen therapy in the management of this group of patients. METHODS: Eighteen diabetic patients with ischaemic, non-healing leg ulcers were recruited in a double-blind study. Patients were randomly assigned either to receive 100percent oxygen (treatment group) or air (control group), at 2.4 atmospheres of absolute pressure for 90 minutes daily, for a total of 30 treatments. Wounds surface areas were measured at baseline and then at 2, 4, 6, 12 weeks and 6months. Quality of life was assessed using the generic form SF-36 Health Survey. RESULTS: At 12 weeks, healing with complete epithelialisation was achieved in 13 out of 19 ulcers in the treatment group compared to 4 out of 14 ulcers in the control group. The median decrease of the wound areas in the treatment group was 96 percent (SD +/- 36) and in the control group was 41 percent (SD +/- 39), p = 0.043 (Mann-Whitney). There was no difference in major amputation rate between the groups. Patients in the treatment group reported significant improvement in vitality, mental health and general health as assessed by the SF-36 (p = 0.01, 0.05 and 0.008 respectively). CONCLUSION: Hyperbaric oxygen therapy enhanced the healing potential of ischaemic, non-healing diabetic leg ulcers and may be used as a valuable adjunct to conventional therapy when reconstructive surgery is not possible.