This is the first in a series of six evidence-based guidelines for type 2 diabetes produced through a collaborative programme between the Royal College of General Practitioners, the British Diabetic Association, the Royal College of Physicians and the Royal College of Nursing.1 The project is being directed by Professor Allen Hutchinson at the School of Health and Related Research, Sheffield.
The key features of these guidelines are as follows:
|They are evidence based, where evidence is available|
|In areas where evidence is lacking this is made clear, and the consensus methods are clearly described|
|Recommendations are explicitly linked to evidence where it is available|
|The recommendations, methods and conclusions of the guideline are explicit and transparent.|
For each guideline a clinical working group was established, and the whole project was overseen by an advisory group, a recommendations panel and a project management group.
There was a common search strategy for each of the guidelines to ensure that all relevant material was gathered for assessment. There was also a common classification of evidence and grading of recommendations (see Table 1).
The draft footcare guideline then underwent an extensive review process by members of the partner organisations. For the RCGP, this included distribution to each member of the RCGP Council for comment. This has resulted in a delay of some 15 months between circulation of the initial draft and final publication.
The guideline itself is a double-sided A4 document (see Figure 1, below), but a much more detailed version which includes the evidence review has also been written.
|Front of the A4 version of the guideline on the prevention and management of diabetic foot ulcers|
|Reverse of the A4 version of the guideline on the prevention and management of diabetic foot ulcers|
Although there have been guidelines published on the prevention of diabetic foot problems in the past 20 years, few have been evidence based.
Footcare is often described as the 'Cinderella' complication of diabetes, where there has been little research. In that situation, prevention advice and ulcer treatment may be based on local custom and practice, and is often not backed up by evidence.
There has also been a false perception among many healthcare workers that little can be done to prevent diabetic foot problems and their inexorable decline into gangrene and amputation.
There was therefore an urgent need for a thorough and systematic review of the evidence to inform practice, to highlight the steps that can be taken to prevent amputation, and to improve care.
The search strategies employed by the guideline development team are comprehensive and robust. They do, however, reveal the paucity of good, randomised controlled trial evidence for diabetic foot care in general, and for the treatment of diabetic foot ulceration in particular.
The guideline concludes that:
|There is inadequate evidence to assess the relative effectiveness of different antibiotic regimens for treating serious diabetic foot infections (III)|
|There is inadequate evidence to demonstrate whether antibiotics are more effective than placebo and standard wound care in healing superficial or skin deep ulcers (II)|
|There is insufficient evidence to support the effectiveness of any type of protective dressing, or topical application, over any other for treating diabetic foot ulcers. (Ib)|
These conclusions provide a challenge for researchers to come up with well-designed multicentre studies, with sufficient numbers of similar ulcers and appropriate randomisation to answer these important questions.
This lack of evidence affects the treatment of established foot ulcers, most of which is carried out in secondary care settings.
There is clearer evidence upon which to base recommendations about the care of the diabetic foot in the community, where the aim is to prevent ulceration. Here the guideline sets down recommendations and evidence for regular annual foot examination, the detection of feet at risk of ulceration and the importance of appropriate education.
The St Vincent Declaration target for diabetes footcare is a 50% reduction in amputations for diabetic gangrene within 5 years.
The UK St Vincent subgroup looking at diabetic footcare proposed a threefold strategy to achieve the target in their report.2 The components of this strategy were:
|Annual examination to detect feet at risk of ulceration|
|Further intensive education and careful follow-up of those at risk|
|Prompt referral of foot infections and ulcers to the local multidisciplinary footcare team.|
The guideline confirms this approach and details the evidence to back it up.
Diabetic peripheral neuropathy causes numbness in the feet. This loss of protective pain sensation is an important cause of and predictor of ulceration. There has, however, been debate as to how best to screen for neuropathy in the community.3
The guideline states that identification of neuropathy based on insensitivity to a 10g nylon monofilament (see Figure 2, below) is convenient and appears cost-effective. (D)
|Figure 2: Testing for insensitivity using a 10 g nylon monofilament|
The concept of an annual screen of everyone with type 2 diabetes for at-risk feet by inspection, palpation of pulses, and insensitivity to the 10g nylon monofilament is reinforced by this guideline. (A)
Such testing takes only a couple of minutes and requires no expensive equipment. It needs to be performed as part of the annual review of everyone with type 2 diabetes, and can do much towards preventing ulcers.It can be done by a GP, practice nurse, footcare nurse or podiatrist. It doesn't matter who does it as long as it gets done.
Those found to have at-risk feet can then receive extra footcare education and frequent review, to prevent the development of ulceration. This strategy, the guideline confirms, reduces morbidity and is cost-effective. (Ib)
When a person with diabetes develops an ulcer, the guideline recommends that he/she should receive prompt appropriate treatment, which will include intensive antibiotic therapy and local debridement where necessary. This will necessitate referral to a local multidisciplinary footcare team, and may involve admission.
These services may not be present in all areas of the UK. When they are absent, patients with diabetes and foot ulceration may be referred for treatment to a variety of consultants in secondary care including general surgeons, vascular surgeons, ortho-paedic surgeons, consultant physicians or even casualty departments.
The variety of referral pathways may delay the prompt and appropriate treatment that the guideline recommends as important. It is therefore vital to ensure that local referral pathways from primary to secondary care are clearly defined and well known to local GPs.
Once the person with diabetes and a foot ulcer reaches the multidisciplinary footcare team, there are treatment recommendations outlined in the guideline, but there is a relative lack of trial evidence to support them.
The guideline recommendation on wound dressings states that in the absence of strong clinical or cost effectiveness evidence, healthcare professionals should use wound dressings that best match clinical experience, cost, patient preference and site of the wound.(D)
It also recommends that wounds should be closely monitored and dressings changed regularly.(D)
There is a large difference in the costs of different dressings. It is clear that more research is needed on wound care and dressings, to determine which are the most cost-effective.
The longer version of the guideline, which contains the evidence review, comments on some of the new dressings and techniques that are becoming available for the treatment of foot ulcers. These include cultured human dermis, growth factors and granulocyte-colony stimulating factors. It concludes that more evidence is needed before recommendations for their use can be clearly made.
This guideline needs to be made widely available to all healthcare professionals who deliver diabetes care, especially those doing annual diabetes checks in the community.
It provides the recommendations and evidence base for a simple foot examination to identify at-risk feet and a strategy for further education and follow-up. It also emphasises the need for prompt and active treatment of ulcers and foot infection.
The implementation of these simple recommendations will go a long way towards achieving the St Vincent goal of a 50% reduction in amputations for diabetic gangrene within 5 years.
- The Prevention and Management of Foot Ulcers: An evidenced-based guideline. London: RCGP, 1999.
- Edmonds M, Boulton A, Buckenham T, Every N et al. Report of the diabetic foot and amputation group of the St Vincent Taskforce. Diabetic Med 1996; 13: S27-42.
- Gadsby R, MacInnes A. The at-risk foot: the role of the primary care team in achieving St Vincent targets for reducing amputation. Diabetic Med 1998; 15(Suppl 3): S61-4.