Several small studies have indicated that the systemic administration of
pentoxifylline may accelerate healing of venous
leg ulcers. The goal of this study was to further evaluate these findings in a larger scale placebo controlled trial and to explore the effect of the dose of
pentoxifylline on healing. The study used a prospective, randomized, double-blind, parallel group placebo controlled design in a multicenter outpatient setting. Patients with one or more
venous ulcer were enrolled, with all patients receiving standardized compression bandaging for treatment for their
ulcers. Patients were 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 131 patients. Patients receiving 800 mg three times a day of
pentoxifylline healed faster than placebo (p = 0.043, Wilcoxon test). The median time to complete healing was 100, 83, and 71 days for placebo,
pentoxifylline 400 mg, and
pentoxifylline 800 mg three times a day, respectively. Over half of all patients were
ulcer free at week 16 (placebo) and at week 12 in both
pentoxifylline groups. Whereas the placebo group had only achieved complete healing 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. Treatment with
pentoxifylline was well tolerated with similar drop-out rates in all three treatment groups. Complete
wound closure occurred at least 4 weeks earlier in the majority of patients treated with
pentoxifylline by comparison to placebo. A higher dose of
pentoxifylline (800 mg three times a day) was more effective than the lower dose. We conclude that
pentoxifylline is effective in accelerating healing of
leg ulcers.