VOL: 98, ISSUE: 36, PAGE NO: 39
Michael Stacey, University of Western Australia, Fremantle
Vincent Falanga, Boston University, USA;William Marston, University of North Carolina, USA;Christine Moffat, Thames Valley University, London;Tania Phillips, Boston University School of Medicine, USA;R. Gary Sibbald, University of Toronto, Canada;Wolfgang Vanscheidt, Universitèts-Hautklinik, Freiburg, Germany;Christina Lindholm, Karolinska Hospital, Stockholm, Sweden
The appropriate management of venous leg ulcers is a continuing challenge for health care professionals, despite the publication of numerous useful management guidelines and systematic reviews (Cullum et al, 1998; Scottish Intercollegiate Guidelines Network, 1998; Fletcher et al, 1997; Alexandra House Group, 1992; Kunimoto et al, 2001; Palfreyman et al, 1998; Nelson et al, 1996; Agus et al, 2001). Approximately 1-2% of the general population suffer from a poorly healing ulcer of the lower extremity in their lifetime (Callam et al, 1985).
More effective management strategies are required which are based on the results of randomised controlled trials (RCTs), improved organisational structures and multidisciplinary cooperation. It is also vital that any evidence-based recommendations are widely disseminated and easily implemented to maximise benefits to patients.
Compression therapy remains the cornerstone of therapy in venous leg ulcers (Ramelet, 1999). This article provides an up-to-date, qualitative overview of the literature and expert consensus on the use of compression therapy in the treatment of venous leg ulcers. The work was carried out by a distinguished international, multidisciplinary group, and aims to continue and expand on the excellent work reported in previous guidelines, in particular the RCN and Scottish Intercollegiate Guidelines Network guidelines (Cullum et al, 1998; Scottish Intercollegiate Guidelines Network, 1998).
The main outcome of this cooperation was to produce a management pathway in algorithm form (Fig 1), designed for easy implementation by physicians, nurses and other health care professionals. It is based on the best quality data reviewed in the current literature and, where this was not available, on consensus opinion from experts in the field. These findings have already received additional input from other health care professionals at a recent international symposium. It is hoped that this algorithm will be a useful tool in improving the management of venous leg ulcers.
A literature search using MEDLINE from 1966 and EMBASE from 1974 was carried out using the keywords compression therapy/treatment, venous leg ulcers, clinical paper/article/trial or review, and selecting human, priority journals. Relevant journals and conference proceedings from the past five years were manually searched and reviewed for relevance. Existing guidelines such as those from the RCN and the Scottish Intercollegiate Guidelines Network provided valuable information.
The panel members also contributed additional papers. An experienced clinical researcher in the field provided a large number of publications in non-English language journals. Nearly 150 papers were selected for detailed review and were graded using a hierarchy of evidence, tool-based on an example by Guyatt et al (1995). These papers provided the evidence base for the algorithm. A full list of references reviewed is available on request.
The panel drafted an algorithm that was discussed at a meeting in September 2001, and the algorithm was subsequently presented for comment at an international symposium during Innovations in Wound Care Week in Cardiff UK.
There remains some debate on the definitions of certain aspects of compression therapy. For the purpose of designing the management algorithm, the panel agreed on a number of terms (Box 1).
Elastic compression (long-stretch) bandages exert high compression during rest and exercise, whereas inelastic (short-stretch) bandages produce passive compression - mainly when the calf muscle contracts, increases in volume and creates pressure against the bandage. At rest, inelastic compression bandages exert pressure dependent on the tension used during application.
The algorithm design (Fig 1) was based on a review of the available literature and expert consensus. To ensure ease of use and effectiveness it has been kept as simple and straightforward as possible. The algorithm can be broken down into four stages:
- Recommendations for treatment;
Accurate assessment is necessary to ensure the correct aetiology of the ulceration and to exclude patients with arterial disease, for whom compression is dangerous. A number of non-invasive methods are used to confirm venous disease when a patient presents with suspected venous disease, including:
- Hand-held, continuous-wave Doppler ultrasound measurement of ankle brachial pressure index (ABPI) - this is regarded as the most reliable way of detecting arterial insufficiency (Moffat and O’Hare, 1995). However, in patients with diabetes Doppler waveform analysis and toe pressure measurements are the more reliable methods;
- Duplex ultrasonography - this measures blood flow velocity through a vessel and is the primary method of identifying venous obstruction or abnormal venous reflux (Nicolaides, 2000);
- A number of plethysmographic methods, including air and photo plethysmography, which may be used to assess venous function;
A number of other investigations should take place to exclude disorders such as rheumatoid arthritis, diabetes, renal failure, anaemia, tumours and autoimmune disorders.
Following assessment, the patient with a leg ulcer can be assigned to one of four groups:
- Patients with a venous leg ulcer require compression therapy;
- Patients with an arterial leg ulcer or with a significant arterial component require referral to a vascular specialist;
- Patients with mixed arterial and venous ulcers require reduced compression therapy with referral to a vascular specialist, particularly if there is pain at rest;
- Patients with ulcers from other sources require disease-specific treatment and compression therapy for oedema control.
There remains some debate on the definition of arterial insufficiency by ankle-brachial pressure index (ABPI). The scope of the mixed arterial/venous ulcer groups was agreed based on the panel’s clinical experience rather than demonstrated in the literature.
Recommendations for treatment
The algorithm focuses on the appropriate use of compression therapy in the treatment of venous leg ulcers. It is widely accepted that sustained compression provides the mainstay of treatment in venous leg ulcers. This should be supported with adjunctive medical and surgical therapy, appropriate dressings and patient education.
Sustained compression is provided by multi-layer elastic or inelastic bandage systems. There is now considerable evidence to show that this form of sustained high compression improves ulcer healing and provides quality of life and cost benefits. Three systematic reviews have shown that compression therapy does increase the healing rate of venous leg ulcers (Fletcher et al, 1997; Palfreyman et al, 1998; Cullum et al, 2001).
Multi-layer high-compression bandaging improves healing of venous leg ulcers when compared with single-layer, low-compression bandaging, although there is little reliable evidence, to date, of large RCTs which directly compare four-layer compression to three-layer or two-layer bandaging (Fletcher et al, 1997; Nelson et al, 1995). To date, there is insufficient data to suggest a difference in benefit in terms of ulcer healing between elastic and inelastic compression.
These multi-layer bandage systems are complemented by reduced compression systems (15-25mmHg) for patients who cannot tolerate high-compression systems and compression stockings. Intermittent pneumatic compression (IPC) is a useful adjunct to multi-layer compression and has been shown to improve ulcer healing rates when used with multi-layer compression (Fletcher et al, 1997).
Medical and surgical treatment
A number of adjunctive medical therapies are currently in use without unequivocal support in the literature, but discussion of these is beyond the scope of this article. There is also increasing realisation that chronic wounds, such as venous ulcers, benefit from an overall approach aimed at optimising the wound bed. This approach, termed wound bed preparation, includes a number of aspects critical to wound care, such as elimination of excessive exudate and bacterial burden, debridement and elimination of necrotic tissue, angiogenesis and the formation of a wound matrix that promotes re-epithelialisation.
There is also emerging evidence that skin substitutes may be beneficial in the treatment of hard-to-heal venous leg ulcers (especially in those with a duration of more than one year) when used in conjunction with multi-layer compression bandaging (Falanga and Sabolinski, 1999; Harding, 2000). Other biological agents, such as growth factors and protease inhibitors, are currently being evaluated for their efficacy in the management of venous leg ulcers.
Many patients with leg ulcers suffer pain that can adversely affect their quality of life and may influence speed of healing. Reduced compression should be used until pain and oedema resolves, then high-compression bandaging can be introduced. In most cases, appropriate dressings or oral analgesics can effectively manage pain, although skin grafting may be required in cases of intractable pain.
Appropriate dressing selection
Patients with leg ulcers are prone to contact sensitivity, particularly from wool alcohols, topical neomycin, framycetin, cetylstearyl alcohols and rubber mixes present in many dressings, ointments and creams (Wilson et al, 1991). Emphasis should be placed on allergen avoidance to allow optimal wound healing. However, this remains a difficult management issue in individual patients.
Factors that encourage ulcer healing, such as improved nutritional status, appropriate bandage use and mobility, depend on patient involvement. Education to improve patient understanding of the condition will aid compliance to therapy.
Mobile and immobile patients
Reduced mobility and reduced ankle function, as well as other factors, such as ulcer size and duration, have been shown to independently affect healing rates (Franks et al, 1995; Margolis, 1999). Inelastic bandages lose pressure when leg oedema is reduced, so multi-layer (elastic) compression is recommended as first-line therapy for immobile patients with venous leg ulcers. However, these recommendations are based on expert opinion rather than being demonstrated conclusively in the literature at this stage.
Elastic stockings can be used as second-line therapy in mobile patients, particularly those who are young and working, or are unable or unwilling to tolerate multi-layered compression.
Reasons for referral
Patients should be referred for specialist opinion in a number of cases. If a patient is unable to tolerate compression a specialist may be able to identify the reason for the problem, take the patient through a process to temporarily reduce compression and control pain, educate the patient in the importance of sustained compression, then reinstate treatment.
During acute infection patients with venous leg ulcers may require reduced compression for a period of time. The level of compression should be tailored according to symptoms, such as the level of pain.
The panel has recommended a definition of failure to heal as no reduction in ulcer size in one month. Patients with ulcers10cm2 are likely to take a long time to heal, and skin grafting may be required.
Following healing of the ulcer, steps must be taken to minimise the risk of recurrence by using compression hosiery and maintaining education and support of the patient. Control of oedema by elevation and use of compression hosiery for life may be required. Compression hosiery should be applied at the highest level of pressure, subject to patient compliance and dexterity.
This new algorithm, based on a comprehensive review of the literature and expert consensus, confirms the role of sustained compression (elastic and inelastic) as first-line therapy for venous leg ulcers.
Reduced compression and compression hosiery are useful alternatives in patients with additional arterial disease or those who cannot tolerate multi-layer bandaging. Intermittent pneumatic compression is a valuable adjunctive therapy in the treatment of venous leg ulcers, although there is a need for further evidence-based findings on these techniques. In addition, there is a need for further RCTs on the other medical and surgical therapies to be used in conjunction with compression therapy.
It is hoped that this algorithm provides a useful working tool for primary care physicians and nurses to provide appropriate care based on the latest findings in the literature.
Expert panel on behalf of the International Leg Ulcer Advisory Board: Michael Stacey, University of Western Australia, Fremantle; Vincent Falanga, Boston University, USA; William Marston, University of North Carolina, USA; Christine Moffat, Thames Valley University, London; Tania Phillips, Boston University School of Medicine, USA; R. Gary Sibbald, University of Toronto, Canada; Wolfgang Vanscheidt, Universitets-Hautklinik, Freiburg, Germany; Christina Lindholm, Karolinska Hospital, Stockholm, Sweden
These recommendations were compiled by an international expert panel, with complete editorial freedom. All panel members collaborated on this project without remuneration. A small, unrestricted educational grant was provided by Smith and Nephew Medical Limited and used by the panel for coordination and communication.This article was originally published in the EWMA Journal. The copyright for this article is the property of the European Wound Management Association. Consent for reproduction can be obtained from the EWMA.
NT Plus Wound Care will focus on leg ulcer management in the next issue, published on October 29.