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CLINICAL REVIEW:
Deborah A Simon, Francis P Dix, and Charles N McCollum
Management of venous leg ulcers
BMJ 2004; 328: 1358-1362 [Full text]
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Rapid Responses published:

[Read Rapid Response] Pentoxifylline: more evidence of its efficacy
Kieran M Walsh   (4 June 2004)
[Read Rapid Response] Management of venous leg ulcers
Pedro Redondo, Juan Cabrera, Leopoldo Fernández-Alonso   (1 July 2004)
[Read Rapid Response] Management of Venous Leg Ulcers
F R Assinder   (19 August 2004)
[Read Rapid Response] Ulcers and HBO
Aaron Nesoff   (20 August 2004)

Pentoxifylline: more evidence of its efficacy 4 June 2004
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Kieran M Walsh,
Editorial Registrar, bmjlearning.com
BMA House, Tavistock Square, London WC1H 9JR.

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Re: Pentoxifylline: more evidence of its efficacy

Dear Sir,

Simon et al (1) report that the largest placebo controlled, double blind, randomised study of pentoxifylline included only 80 patients.(2)

In fact there were 85 patients but only 80 completed the study. More importantly there is considerable more evidence of the efficacy of pentoxifylline than stated in the Simon's paper.

A systematic review of nine randomised controlled trials containing 572 people compared pentoxifylline with placebo or other treatments, with or without compression.(2) It found that, in patients receiving compression, pentoxifylline significantly increased the number of patients with healed ulcers compared with placebo.(2) More patients receiving pentoxifylline had side effects but this was not statistically significant.

A further randomised controlled trial of 172 people (of whom 160 completed the study) found that pentoxifylline for 6 months significantly increased rates of complete healing compared with placebo.(4) 67% of patients in the pentoxifylline group had a completely healed ulcer at the end of the study compared to 31% in the placebo group (4).

Yours Sincerely,

Dr. Kieran Walsh.

1. Simon D, Dix P, McCollum C. Management of venous leg ulcers. BMJ, Jun 2004; 328: 1358 - 1362.

2. De Sanctis MT , Belcaro G, Cesarone MR, et al. Treatment of venous ulcers with pentoxfylline: a 12-month double-blind placebo controlled trial. Microcirculation and healing. Angiology 2002;53:S49–S51.

3. Jull AB, Waters J, Arroll B. Oral pentoxifylline for treatment of venous leg ulcers. In: The Cochrane Library, Issue 1, 2002. Oxford: Update Software.

4. Belcaro G, Cesarone MR, Nicolaides AN, et al. Treatment of venous ulcers with pentoxifylline: a 6-month randomized double-blind placebo controlled trial. Angiology 2002;53:S45–S47.

Competing interests: None declared

Management of venous leg ulcers 1 July 2004
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Pedro Redondo,
Director. Department Dermatology
University Clinic, Medical School, University of Navarra, 31080 Pamplona, Spain.,
Juan Cabrera, Leopoldo Fernández-Alonso

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Re: Management of venous leg ulcers

EDITOR-The clinical review of Management of Venous Leg Ulcers by Simon et al is comprenhensive and clear, although some aspects deserve comment (1). We agree that venous hypertension is the underlying cause of venous ulceration. Compression therapy is associated with a protracted course of healing and multiple recurrences. The authors postulate that the future is focused on the role of superficial venous surgery and the use of cultured skin allografts.

Skin closure rapidly occurs when venous hypertension is decreased. The ablation of superficial and perforator vein incompetence provides clinical and hemodynamic improvement in patients with chronic venous ulcers (2).

Subfascial endoscopic perforator surgery has become the surgical technique of choice for perforator ablation, although this approach cannot be adopted in all cases. A study found that 50% of incompetent perforators within 10 cm of the sole of the foot, identified preoperatively by duplex ultrasound were missed at subfascial endoscopy (3). Small interconnected collaterals between the perforators and the skin frequently convey the venous hypertension to the skin area, and surgical procedures are inherently unable to close these vessels. We have recently published a study of 116 patients with chronic venous ulcers treated with ultrasound-guided injection of polidocanol microfoam (UIPM) (4). To reduce venous hypertension UIPM was used to selectively sclerose sources of incompetence. At 6-months`s follow-up, treatment with UIPM achieved complete healing in 83% of patients with median time to healing of 2.7 months. In comparison with the patients treated with allogeneic cultured human skin equivalent of a previously reported series (5), we obtained a highly significant advantage for our overall results (X2 test, P<.001).

UIPM of superficial and perforating valveless veins is a well-tolerated and effective outpatient procedure. Major advantages of sclerosant in microfoam form with respect to classic liquid sclerosants include selective effect on endothelium, visibility on ultrasound examination, predictability of outcome, high success rate, and low frequency of recurrence. UIPM may well prove to be the gold standard for treatment of chronic venous ulcers in the future.

1.- Simon DA, Dix FP, McCollum ChN. Management of venous leg ulcers. BMJ 2004 ; 328: 1358-62.

2.- Pierik EG, van Urk H, Hop WC, Wittens CH. Endoscopic versus open subfascial division of incompetent perforating veins in the treatment of venous leg ulcerations: a randomized trial. J Vasc Surg 1997; 26: 1049-54.

3.- Stacey MC, Burnand KG, Layer GT, Pattison M. Calf pump function in patients with healed venous ulcers is not improved by surgery to the communicating veins or by elastic stockings. Br J Surg 1988; 75: 436-9.

4.- Cabrera J, Redondo P, Becerra A, et al. Ultrasound-guided injection of polidocanol microfoam in the management of venous leg ulcers. Arch Dermatol 2004; 140: 667-73.

5.- Falanga V, Margolis D, Alvarez O, et al, and the Human Skin Equivalent Investigators Group. Rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. Arch Dermatol 1998; 134: 293-300.

Competing interests: Dr J. Cabrera have a financial interest in the commercial development of the patented microfoam (BTG International Limited). Provensis Ltd, a subsidiary of BTG, has developed the patented microfoam concept into a pharmaceutical product, Varisolve, which is currently used in clinical trials in Europe and the United States.

Management of Venous Leg Ulcers 19 August 2004
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F R Assinder,
Retired General Practitioner
High Mead, 3 Pine Crescent, Carshalton Beeches, Surrey, SM5 4HQ

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Re: Management of Venous Leg Ulcers

The Clinical Review by Simon et al stresses the difficulty of treatment and makes the point that prevention would be better than cure, both cheaper and better for the patient.

As the 'patient's perspective' illustrates, many leg ulcers results from a skin breaking injury which becomes infected. More thought should therfore be given to the immediate treatment of such injuries to vulnerable patients.

The usual treatment involves the application of non-adherent dressing which is then changed at regular intervals by a nurse. Sadly in many such cases the wound becomes infected and an ulcer results.

If on the other hand the non-adherent dressing is applied initially and then left untouched for at least six weeks, then in my experience, the wound usually heals by first intention.

Even if some blood oozes through the original dressing or it becomes superficially soiled it should simply be covered over by a clean bandage and left in place.

The regular replacement of even the best of non-adherent dressings tends to damage early epithelialisation and increases the risk of infection. Only in the relatively rarer cases when the wound becomes infected need one resort to more frequent dressings or initiate ulcer treatment regime.

Competing interests: None declared

Ulcers and HBO 20 August 2004
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Aaron Nesoff,
Physician
Peninsula Hospital Center, Far Rockaway, NY 11691

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Re: Ulcers and HBO

The clincal review article "Management of Venous Leg Ulcers" in the August 2004 issue of BMJ USA did a good job except for one omission. It did not consider the use of hyperbaric oxygen therapy (HBO). The recurrence rate is, as per your article, 26% at one year. It is suggested in your article that higher compression may reduce this rate of recurrence. HBO therapy increases the tissue oxygen gradient across the ulcer forcing new vascular growth thereby strengthening the healed area and reducing recurrence of the ulcer. I believe the article is quite incomplete with this omission.

Competing interests: None declared