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.