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Clinical Trial
. 1999 Oct 2;319(7214):875-8.
doi: 10.1136/bmj.319.7214.875.

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

J J Dale  1 , C V Ruckley, D R Harper, B Gibson, E A Nelson, R J Prescott
Affiliations
Clinical Trial

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

J J Dale et al. BMJ. .

Erratum in

  • BMJ 2000 Jan 1;320(7226):30

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.

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Figures

Figure
Figure
Life table analysis of time to complete healing of all ulcers on reference leg
See this image and copyright information in PMC

Comment in

References

    1. Callam MJ, Harper DR, Dale JJ, Ruckley CV. Chronic ulcer of the leg: clinical history. BMJ. 1987;294:1389–1391. - PMC - PubMed
    1. Cornwall JV, Dore CJ, Lewis JD. Leg ulcers: epidemiology and aetiology. Br J Surg. 1986;73:693–696. - PubMed
    1. Bosanquet N. Costs of venous ulcers: from maintenance therapy to investment programmes. Phlebology. 1992;(7 suppl)1:44–46.
    1. Callam MJ, Harper DR, Dale JJ, Brown D, Gibson B, Prescott RJ, et al. Lothian and Forth Valley leg ulcer healing trial. Part 1: elastic versus non-elastic bandaging in the treatment of chronic leg ulceration. Phlebology. 1992;7:136–141.
    1. Smith JM, Dore CJ, Charlett A, Lewis JD. A randomised trial of biofilm dressing for venous leg ulcers. Phlebology. 1992;7:108–113.

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