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.

METHODS

A single blind randomized trial.

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.