Low-dose topical recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) therapy for chronic venous leg ulcers, 10-year follow-up

Background The treatment of leg ulcers is an enormous problem worldwide. Chronic venous ulceration affects 1% of the population and often has a protracted course. Recurrence rate is high, ranging up to 69% in the first year after healing. Objectives To determine whether topical application of low-dose topical recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) is safe in venous leg ulcer treatment, and whether it accelerates healing rates and reduces recurrence rates. Materials and methods Consecutive patients with chronic venous leg ulcers received topical treatment with low-dose rhu GM-CSF (10 mu g/mL 0.9% sodium chloride solution; 1.0-2.3 mu g rhu GM-CSF/cm(2)) in combination with treatment of venous insufficiency. All patients were previously treated with other topical wound remedies for several weeks (median 8 weeks) without success. Results In 119 of 130 patients, the wounds healed completely (91.5%). No local or systemic adverse reactions were observed. The mean time to healing was 24 weeks (median 14 weeks). Median follow-up of the 119 patients with healed ulcers was 84 months. The recurrence rates were 5.2% after 1 year, 18.9% after 4 years and 32.0% after 10 years. Conclusions Topical low-dose rhu GM-CSF proved to be safe and highly effective. Healing rates were comparable to those reported in the ESCHAR study (Effects of Surgery and Compression on Healing And Recurrence in venous ulceration) and recurrence rates were the lowest reported in the literature. Topical therapy with rhu GM-CSF can be applied in an outpatient setting and does not require hospitalization.