Randomised,double blind placebo controlled trial of pentoxifylline in the treatment of venous leg ulcers |
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| Authors: | J J Dale C V Ruckley D R Harper B Gibson E A Nelson R J Prescott |
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| Affiliation: | aDepartment of Vascular Surgery, Edinburgh Royal Infirmary, Edinburgh EH3 9YW, bDepartment of Surgery, Falkirk and District Royal Infirmary, Falkirk FKI 5QE, cDepartment of Health Sciences and Clinical Evaluation, University of York, Hesslington, York YK1 5DD, dMedical Statistics Unit, University of Edinburgh, Medical School, Edinburgh EH8 9AG |
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| Abstract: | ObjectiveTo 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.DesignRandomised, double blind placebo controlled trial, parallel group study of factorial design, permitting the simultaneous evaluation of alternative pharmaceutical, bandaging, and dressings materials.SettingLeg ulcer clinics of a teaching and a district general hospital in southern Scotland.Participants200 patients with confirmed venous ulcers and in whom other major causal factors were excluded.InterventionsPentoxifylline 400 mg three times daily or placebo.ResultsComplete healing occurred in 65 of the 101 (64%) patients receiving pentoxifylline and 52 of the 99 (53%) patients receiving placebo.ConclusionsThe 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
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