Systemic treatment of venous leg ulcers with high doses of pentoxifylline:efficacy in a randomized, placebo-controlled trial

Several small studies have indicated that the systemic administration of pe ntoxifylline may accelerate healing of venous leg ulcers. The goal of this study was to further evaluate these findings in a larger scale placebo cont rolled trial and to explore the effect of the dose of pentoxifylline on hea ling. The study used a prospective, randomized, double-blind, parallel grou p placebo controlled design in a multicenter outpatient setting. Patients w ith one or more venous ulcer were enrolled, with all patients receiving sta ndardized compression bandaging for treatment for their ulcers. Patients we re also randomized to receive either pentoxifylline 400 mg, pentoxifylline 800 mg (two 400 mg tablets), or placebo tablets three times a day for up to 24 weeks. The main outcome measure was time to complete healing of all leg ulcers, using life table analysis. The study was completed as planned in 1 31 patients. Patients receiving 800 mg three times a day of pentoxifylline healed faster than placebo (p = 0.043, Wilcoxon test). The median time to c omplete healing was 100, 83, and 71 days for placebo, pentoxifylline 400 mg , and pentoxifylline 800 mg three times a day, respectively. Over half of a ll patients were ulcer free at week 16 (placebo) and at week 12 in both pen toxifylline groups. Whereas the placebo group had only achieved complete he aling in half of the cases by week 16, all of the subjects remaining in the group receiving the high dose of pentoxifylline had healed completely. Tre atment with pentoxifylline was well tolerated with similar drop-out rates i n all three treatment groups. Complete wound closure occurred at least 4 we eks earlier in the majority of patients treated with pentoxifylline by comp arison to placebo, A higher dose of pentoxifylline (800 mg three times a da y) was more effective than the lower dose. We conclude that pentoxifylline is effective in accelerating healing of leg ulcers.