Limb salvage in extensive diabetic foot ulceration: an extended study using a herbal supplement.

OBJECTIVE To further study the clinical value of a herbal supplement in the treatment of chronic foot ulcers in diabetic patients. DESIGN Double-blind randomised, placebo-control trial. SETTING Two general hospitals in Hong Kong. PATIENTS Eighty patients were recruited according to strict selection criteria. INTERVENTIONS Clinical measures included standard antidiabetic treatment, daily wound care including antiseptic bath, debridement, toe removal for gangrene when necessary, and the daily consumption of a herbal drink or placebo. MAIN OUTCOME MEASURES The primary outcome was limb salvage. Secondary outcomes included: granulation maturation, local temperature and circulatory changes, tumour necrosis factor-alpha levels, and adverse events. RESULTS Limb salvage was achieved in 85% of the patients. Among the early failures, three each came from the treatment and placebo groups. After shifting to herbal treatment (without unblinding of the original treatment), all were rescued in those initially assigned to herbal concoction (6 out of 6) while only 50% (6 out of 12) were rescued from among those initially assigned to placebo. The speed of granulation maturation, and decline in tumour necrosis factor-alpha levels indicating control of inflammation, were also more favourable with the herbal group. No serious adverse events were observed. CONCLUSION The herbal adjuvant therapy was effective in helping the healing of chronic diabetic ulcers.