Beraprost sodium for chronic diabetic foot ulcer: a randomized controlled trial in thammasat university hospital.

BACKGROUND: Chronic diabetic foot ulcer has a high rate of healing failure. Beraprost sodium, oral form of prostaglandin I2 analogue, maybe used for increasing wound healing. OBJECTIVE: To compare the healing rate of chronic diabetic foot ulcer between Beraprost sodium and control groups. DESIGN: A single blind randomized trial. MATERIALS AND METHODS: Fifty non-healed chronic diabetic foot ulcer patients were randomized to be the study and control groups. Beraprost sodium was prescribed in the study group according to protocol. RESULTS: At 6th week follow up, median wound healing rate in the study group was significantly higher than in the control group with the rate of 88.1% and 33.3%, respectively. Complete wound healing in the study group was also significantly higher than in the control group (48%:8%). In the study group, 9 patients (37.5%) could be administered with recommended dose. Side effects were headache in 14 patients (58.3%) and palpitation in one patient (4.2%). One patient was discontinued for severe headache. CONCLUSIONS: The use of Beraprost sodium in chronic diabetic foot ulcer patients significantly increases the wound healing rate. Headache was the common side effect.