Recombinant human granulocyte-macrophage colony-stimulating factor appliedlocally in low doses enhances healing and prevents recurrence of chronic venous ulcers

Background Chronic venous leg ulcers have a major medical and economic impa ct on the elderly worldwide. Healing of the large ulcers (>10 cm(2)) occurs only in two-thirds of the patients and reulceration of healed ulcers recur s in one-third within 1 year. Because both healing and relapse rate influen ce greatly a patient's quality of life and the overall cost of treatment, e very effort should be made to improve these two parameters. Objective To determine the safety and efficacy of topical low-dose recombin ant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) for the treatment of venous ulcers, and to document any improvement in healing rates. Methods Thirty-eight patients (29 women, 9 men; median age, 74 years) with chronic venous insufficiency were treated with topical rhu GM-CSF (5 mu g/m L 0.9% sodium chloride solution), followed by application of a compression dressing. All subjects were treated as outpatients. Results Complete healing was observed in 47 of the 52 ulcers (90.4%). The a verage healing time was 19 weeks. No systemic or local side-effects from th e therapy were observed. Nine chronic ulcers, previously refractory to conv entional treatment (pretreatment for more than 46 weeks), showed the same r esponse rate (9/8, or 88.9%) and healing time (mean, 19 weeks). After 40 mo nths, no reulceration of the healed ulcers was observed, but two patients d eveloped new ulcers on the same leg. Healing remained stable, with excellen t cosmetic results. Conclusions In this first study, topically applied low-dose rhu GM-CSF was a safe treatment for chronic venous leg ulcers. Healing rates were signific antly increased and relapse rates were minimal.