Randomised, double blind placebo controlled trial of pentoxifylline in the treatment of venous leg ulcers.

OBJECTIVE To determine whether pentoxifylline 400 mg (Trental 400) taken orally three times daily, in addition to ambulatory compression bandages and dressings, improves the healing rate of pure venous ulcers. DESIGN Randomised, double blind placebo controlled trial, parallel group study of factorial design, permitting the simultaneous evaluation of alternative pharmaceutical, bandaging, and dressings materials. SETTING Leg ulcer clinics of a teaching and a district general hospital in southern Scotland. PARTICIPANTS 200 patients with confirmed venous ulcers and in whom other major causal factors were excluded. INTERVENTIONS Pentoxifylline 400 mg three times daily or placebo. MAIN OUTCOME MEASURE Complete healing (full epithelialisation) of all ulcers on the trial leg. RESULTS Complete healing occurred in 65 of the 101 (64%) patients receiving pentoxifylline and 52 of the 99 (53%) patients receiving placebo. CONCLUSIONS The difference in the healing rates between patients taking pentoxifylline and those taking placebo did not reach statistical significance.