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Leg Ulcers

A review of research in nursing management in the community

A detailed review of this important subject, commissioned by the Department of Health, has been conducted by Dr Nicky Cullum of the Department of Nursing in Liverpool [1]. This is an important and common disorder, and Nicky Cullum's review should be read by those treating leg ulcers in the community, especially nurses. It is easy to read, thorough and is a statement not only of where we are now, but also outlines the research agenda and research methods which should be used to make progress.

The two objectives of the report were:-
  • To critically review the research-based information which underpins the nursing management of leg ulcer patients in the community.
  • To highlight those areas where further research and development is required to inform nursing practice.

What are leg ulcers?

The best definition is that a leg ulcer is tissue breakdown on the leg or foot due to any cause. They occur in association with a range of disease processes, most commonly with venous and/or arterial disease.

Those of venous origin are associated with venous hypertension arising from venous damage. How venous hypertension is translated into full-thickness skin defects is not clear, though fibrin deposits, decreased fibrin breakdown and white cell accumulation have been implicated.

Leg ulcers occur in patients with rheumatoid arthritis and diabetes, and may occasionally be self-inflicted either inadvertently or deliberately. What part nutritional or biochemical factors contribute to leg ulcers in not clear.

How big is the problem?

Two major studies in the UK have provided similar figures for the prevalence of active ulceration at 0.15 - 0.18%; that is 450 patients per health district of 250,000 population and 100,000 patients in the UK. Risk factors for leg ulcers are increasing age, female sex and venous disease.

The graph shows the increasing prevalence of leg ulcers in over 65s. The prevalence of a history of leg ulcers in this population was 3.6%, suggesting that only 20-25% of ulcers are open at any time. It has been suggested that nearly 1% of the population may be affected by leg ulceration at some time during their lives.

Leg ulcers seem to have a typical cycle of healing followed by re-ulceration and re-healing. In surveys, two-thirds of patients with leg ulcers were already experiencing a recurrence, and a third had experienced four or more episodes of ulceration.

When the ulcers are open, they tend to be present for some time. In cross-sectional surveys, half of all ulcers had been open for 9 - 12 months, 20% open for two years and 8% open for over five years.

Leg ulcers begin before the age of 40 years in 22% of those affected, and a significant minority (18%) were in full-time employment; in these patients, earning capacity was affected in 40%.

How is leg ulcer treatment organised?

Although delivery of care varies, between 60% and 90% of patients are managed entirely in the community. District Nurses are mainly responsible for the delivery of leg ulcer care along with Practice Nurses; fewer than 10% of patients are managed in hospital clinics. Some 8% - 22% of District Nurses' caseload comprises leg ulcer treatment.

There is a little evidence to show whether differences in health care delivery can improve leg ulcer healing, but there are suggestions that District Nurses' expectations of ulcer healing are low.

What is the cost of treating leg ulcers?

There are few reports, and the bases for costings are not explicit. The best estimate of the total cost in the late 1980s was £100-£120 million a year; other estimates have ranged up to £600 million a year.

Costs on an individual patient basis have ranged from £1100 to over £5000 per patient per year, but a figure of about £2000 per patient per year would appear to be more likely. Based on 100,000 patients in the UK, this would give an annual spend of £200 million.

Which treatments work?

Nicky Cullum's report has a 90-page chapter covering the evidence for the effectiveness of leg ulcer treatments. It covers the fundamentals of wound healing, the place of moisture and the rôle of oxygen in wound healing, the effects of pH and the use of antimicrobial therapies. The chapter also reviews debridement, compression bandaging and about 15 other treatments and issues, including relative esoterica like electricity and ulcer healing.

It is not possible to summarise here the results of all of the many studies examined for this report. However, certain points stand out:-
  • No single treatment method stands out as having unsurpassed effectiveness.
  • There are severe methodological problems with almost all of the studies reviewed.
  • Contact sensitivity in patients with leg ulcers is a widespread problem; 50-85% of leg ulcer patients attending dermatology outpatients clinics demonstrate sensitivity to one or more allergens. Allergic reactions to lanolin, topical antibiotics, cetyl steryl alcohols, basalm of Peru and parabens may contribute to non-healing and cause discomfort to the patient.


Perhaps the best summary is that the key therapy for people with uncomplicated venous ulcers is compression bandages.

Despite this apparently negative conclusion, there is a wealth of detail in the report, and it provides a solid base of current knowledge for those involved in the treatment of patients with leg ulcers, or those who make policy.

More and better research needed

The review makes the point that so many of the studies conducted in leg ulcers are near worthless because of methodological flaws, not an uncommon experience for those engaged on systematic reviews. Dr Cullum, however, provides some light at the end of the tunnel not just by reciting all the aspects of leg ulcers which desperately need good research, but actually by telling us how that research should be conducted if it is to be of value. Bandolier makes no excuses for repeating them in the box.


Key Issues in Leg Ulcer Research

  • Random allocation of intervention and control groups is mandatory.
  • Prior calculation of sample sizes so that studies have adequate power to discriminate clinically important differences.
  • Clear inclusion and exclusion criteria are needed.
  • The choice of control treatment should be reasonable.
  • Confounding variables (like levels of compression in bandaging) should be avoided by standardising common aspects of intervention and control groups.
  • Trials should be of sufficient duration to demonstrate complete healing rates.
  • All clinically relevant outcomes should be reported - including adverse events and how they are assessed and handled.
  • If possible, details of arterial/venous status should be objective.
  • All patients should be accounted for - the numbers and reasons for withdrawals should be explicit.
  • Additional information, like patient comfort or satisfaction scores, frequency of dressing or bandage changes required, or differences in nursing time or frequency are useful in making assessments of the relative effectiveness of treatments.
  • Measurement of ulcer size is important, and the report gives a good review of this.

RCT of aspirin for leg ulcers

Earlier this year saw the publication of a short report on this subject in The Lancet [2]. This trial fulfilled the majority of the features highlighted above, omitting only the prior calculation of power, and additional information. It was limited to four months, but complete ulcer healing was one outcome.



The study involved 20 patients attending dermatology outpatients with chronic venous leg ulcers over 2 cm diameter who were randomly allocated to treatment or control. The treatment was 300 mg of enteric-coated aspirin or identical placebo, one tablet daily.

Thirty-eight percent of ulcers healed in the patients taking aspirin, compared with none in the placebo group, and twice as many ulcers improved (smaller area) in those taking aspirin compared with placebo.

Although the numbers recruited in this study were small, and the power therefore was low, the differences between the groups was large. This study fulfilled most of the qualities required for research in leg ulcers, and aspirin looks as if it is a useful treatment applicable to a high proportion of patients with leg ulcers. Its use as a prophylactic against recurrence was not tested.

References:

  1. N Cullum. The nursing management of leg ulcers in the community: a critical review of research. Available from Department of Nursing, University of Liverpool, PO Box 147, Liverpool L69 3BX.
  2. AM Layton, SH Ibbotson, JA Davies, MJD Goodfield. Randomised trial of oral aspirin for chronic venous leg ulcers. Lancet 1994 344: 164-5.



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