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. Key messages Leg ulcers cost the NHS around £400 million per annum 50%-75% of venous leg ulcers can be succesfully treated with dressings and compression bandages but take many months to heal A drug that reduced the healing time of venous ulcers would be useful, although no agent has been proved to be effective to date Trials with pentoxifylline, a vasoactive drug used in the treatment of peripheral vascular diseases, as an adjunct to the treatment of venous ulcers have been inconclusive At the 5% level, pentoxifylline had a non-significant effect on healing rates of pure venous ulcers