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

BMJ 1999; 319 doi: https://doi.org/10.1136/bmj.319.7214.875 (Published 02 October 1999) Cite this as: BMJ 1999;319:875

This article has a correction. Please see:

  1. J J Dale, area nursing officer, Lothian health boarda,
  2. C V Ruckley, professor (106025.1304{at}Compuserve.com)a,
  3. D R Harper, consultant surgeonb,
  4. B Gibson, leg ulcer nurse specialistb,
  5. E A Nelson, trial coordinatorc,
  6. R J Prescott, directord
  1. a Department of Vascular Surgery, Edinburgh Royal Infirmary, Edinburgh EH3 9YW
  2. b Department of Surgery, Falkirk and District Royal Infirmary, Falkirk FKI 5QE
  3. c Department of Health Sciences and Clinical Evaluation, University of York, Hesslington, York YK1 5DD
  4. d Medical Statistics Unit, University of Edinburgh, Medical School, Edinburgh EH8 9AG
  1. Correspondence to: C V Ruckley
  • Accepted 9 June 1999

Abstract

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

Footnotes

  • Funding The Lothian and Forth Valley Leg Ulcer Study Group was supported by a grant from the chief scientist of the Scottish Office Home and Health Department. This research was also supported financially by Hoechst Marion Roussel and ConvaTec.

  • Competing interests None declared.

  • Accepted 9 June 1999
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