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The International Consensus and Practical Guidelines on the Management and Prevention of the Diabetic Foot

Nicolaas C. Schaper, MD,* Jan Apelqvist, MD, and Karel Bakker, MD

Address *Department of Endocrinology, University Hospital Maastricht, P.O. Box 5600 AZ, Maastricht 6202 AZ, The Netherlands. E-mail: nsc@sint.azm.nl Current Diabetes Reports 2003, 3:475479 Current Science Inc. ISSN 1534-4827 Copyright 2003 by Current Science Inc.

Diabetic foot ulcers pose a great burden on both the patient and the health care system. A multifactorial approach is necessary in diagnosing and treating these patients, with the input of many different specialists. These different view points and approaches were the basis for the International Consensus on the Diabetic Foot, resulting in a worldwide network of professionals involved in the management of diabetic patients with foot problems. Moreover, several consensus texts were produced and the project resulted in many (local) national initiatives. These activities, which are a continuous process and which are embedded in the International Diabetes Federation, are described in the article.

frequent hospital visits or admissions, and the eventual consequences of an amputation all pose a heavy burden on the patient. Also the demands of the health care system are high. In two studies the direct costs to treat individuals with a foot ulcer were 14 to 15.000 Euro annually [4,5]. Strategies aimed at reducing amputations may reduce costs by 1 million Euro per year per 10,000 diabetic patients [6]. Although most of these figures have been obtained in Europe and the United States, in developing countries foot ulcers are also seen as a rapidly growing problem [1].

The Complexity of Diabetic Foot Disease


In the past decades several cross-sectional and prospective clinical studies have been performed that have delineated the major pathways to ulceration and subsequent amputation [1,7]. Diabetic foot ulcers are usually caused by a combination of factors [1,7]. In one study, the triad neuropathy, deformity, and minor foot trauma was present in more than 60% of the patients treated in two specialized diabetic foot clinics [8]. Edema and ischemia, in combination with other factors, were thought to contribute to ulceration in 37% and 35% of the patients. It usually takes several months for an ulcer to heal, and in this period there is always the risk of foot infection or progressive gangrene, with amputation as the final outcome [1]. Biomechanical off-loading, vascular surgery, aggressive treatment of infection, and meticulous wound care are presently seen as essential elements in the treatment of diabetic foot disease and a multidisciplinary approach is essential [9]. In addition, newer therapies such as hyperbaric oxygen therapy, growth factors, and tissue-engineered products have been introduced, but given the small number of randomized controlled trials it is less clear when and how these different procedures should be used [10]. In many cases patients will be treated by clinicians with a limited multidisciplinary knowledge base and without the necessary diverse management skills. Due to the lack of evidence, the treatment is frequently empiric and is determined by personal preference, the availability of local expertise, and resources [9]. Although many issues remain to be settled, observational studies clearly suggest that specialized multidisciplinary foot clinics can reduce amputation rates and hospital stay, and

Introduction
Diabetic foot ulcers are one of the most feared complications of diabetes and have important effects on the quality of life of affected individuals, whereas at the same time they pose important demands on the health care system in terms of manpower and costs. In this article we describe the development of the International Consensus on the Diabetic Foot, its achievements, the future developments, and which lessons can be learned from this initiative.

The Scope of the Problem


Approximately 15% of all diabetic patients will develop one or more foot ulcers in the course of their disease, and probably 10% of these patients will eventually undergo a major lower extremity amputation [1,2]. Given the rise in subjects with diabetes, the absolute number of patients with foot ulcers will double in the near future when present health care is left unchanged. Diabetic foot ulcers are a major burden both to the patient and the health care system [1,2,3]. Limitation of walking, special footwear,

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probably improve healing rates with a reduction in costs [11 13]. A reduction in amputation rate as high as 75% has been reported [13] and such clinics have been introduced into a number of hospitals throughout the world, but this number still remains (too) small (Bakker, Unpublished data). Major differences in lower extremity amputation rates have been reported in various countries and these differences could be related to severity of disease [9,14]. However, suboptimal care, inefficient use of resources, poor accessibility to health care, and ineffective organization of health care probably also contribute to this large difference in outcome [1417].

The Need for a Consensus


The poor outcome of patients with a diabetic foot ulcer can only be improved if diabetic foot ulcers are placed on the agenda of both health care policy makers and researchers, if its pathology and the necessary skills are taught to all professionals involved, and if both communication and collaboration between these professionals is effective. Concerted action by all health care workers is required for such an approach to be effective, and specific guidelines are needed to realize a uniform high standard of care. Discussion following a diabetic foot meeting in Malvern, UK, in 1996, convinced many of those present and all experts in the field of the need for an international set of definitions and guidelines on prevention and management, and this led to the formation of an International Working Group on the Diabetic Foot (IWGDF). At that time, guidelines had been formulated in several countries but the contents of these guidelines were mutually inconsistent in some instances. In some cases, the group compiling the guidelines was not fully representative of all the disciplines involved in diabetic foot care; some had different target groups, and ambiguities resulted from a lack of clear definitions and terminology. Furthermore, there were no guidelines addressed specifically at policy makers who allocate resources for health care.

The International Working Group on the Diabetic Foot


Members of the Working Group met in 1997 to discuss the feasibility of creating a consensus text on the diabetic foot, for worldwide circulation to diabetic clinics and primary care practitioners with an interest in diabetes mellitus, and to agree on the consensus procedure to be followed, the aims of the guidelines, and items that should be addressed. The goal of the Working Group was to develop evidencebased guidelines, augmented by expert opinion, in order to reduce the impact of diabetic foot disease, by means of cost-effective quality health care. The text was to delineate how and when actions should be taken. Finally, the organization of care and implementation of the guidelines were to be addressed. Given the very broad scope of the problem, it was deemed crucial to have an early consensus on

what should be included and what should be excluded. Every participant was asked to allocate a priority marking to each of 128 possible topics, and the results were circulated before the first meeting of the Working Group. It was decided that three consensus texts should be written for three target groups: policy makers in health care, general health care professionals, and foot care specialists. The first document focuses on the socioeconomic impact of diabetic foot ulcers and the potential for reducing this impact by well-targeted intervention strategies. This text contains elements essential for policy makers involved in planning and allocating health care resources. The second document is the actual Consensus Document that addresses all the essential elements encountered in the field of the diabetic foot. Moreover, this document contains 45 definitions and criteria, creating a common language for the IWGDF documents and improving effective communication between all professionals involved. The target group is every specialist involved in diabetic foot care. This international Consensus Document serves as the source reference for the third document, called the Practical Guidelines, which describe the basic principles of prevention and treatment. The Practical Guidelines are aimed at all health care workers involved in the care of diabetic patients. Given the lack of evidence in 1997, it was also decided that specific antibiotic treatments, different wound care strategies, and wound classification would not be addressed in the documents. During the January 1997 meeting, consensus was reached on the topics to be discussed in the three documents and in each chapter. For each chapter, one or more specialists were assigned as primary writers and the authors were explicitly asked to create chapters containing mainly evidence-based information, augmented where necessary with expert opinion. Moreover, the document should have worldwide application and it was decided that in a second (implementation) phase the principles described would have to be adapted and translated for local use, taking into account regional differences in socioeconomics, accessibility to health care, and cultural factors. An editorial board was chosen to coordinate the project, to review if each chapter was indeed containing the allocated topics, to prevent unnecessary overlap and, if necessary, to assist the authors. In addition, the editorial board was responsible for the final stages in the production of the document. In this consensus process, several lessons were learned. The early definition of the aims and the topics of the three documents helped the editorial board in supporting the authors in their sometimes difficult tasks. Excluding areas in which consensus was unlikely probably increased the chances of obtaining the objectives within the desired time frame. In a later phase it became clear that the common language that was developed during this phase helped the formulation of additional documents on topics not included in the Consensus Document produced in 1999. The editorial board facilitated the consensus process, and its members met on several occasions to discuss each chapter in depth and, if necessary,

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with the original writers. Every time a text had been edited it was redirected to the original writer and the members of the IWGDF for further comments. In this process it also became increasingly clear that evidence-based information was lacking in several areas, rendering the formulation of clear and unequivocal practical guidelines difficult. Therefore, expert opinion was accepted in these areas of uncertainty and all participants had many opportunities to express their ideas or criticisms.

The International Consensus of the Diabetic Foot


At the end of 1997 a preliminary text was sent for comment to a group of 45 experts from 23 countries, representing all continents and all specialties involved in the diabetic foot. This "Full Working Party" included primary care physicians; diabetologists; podiatrists; diabetes nurses; general, vascular, and orthopedic surgeons; internists; and neurologists. Moreover, members from organizations such as the International Diabetes Federation (IDF), American Diabetes Association, European Association for the Study of Diabetes (EASD), and World Health Organization (WHO) participated in the process. The Full Working Party met in 1998 to discuss, adjust, and improve the preliminary consensus text. After this meeting, the preliminary Consensus Document text was rewritten by the original authors, sometimes in collaboration with IWGDF members. Subsequently, every IWGDF member was given the opportunity to comment on the revised texts. The editorial board reviewed all these further comments, adjusting the text where necessary, and the final documents were then produced. All the members of the IWGDF then agreed on and undersigned the final text. The International Consensus on the Diabetic Foot, and the Practical Guidelines were launched during the Third International Symposium on the Diabetic Foot in Noordwijkerhout, The Netherlands, 1999. The Practical Guidelines and a description of the consensus process were published in a scientific journal in 2000 [18] and discussed in peer-reviewed journals.

New Consensus Projects


In the year 2000, three new consensus projects were initiated on the following: wound healing and treatments for people with diabetic foot ulcers; diabetic foot ulcer classification for research purposes; and diagnosing and treating the infected diabetic foot. Three separate documents were produced, the first two are aimed at specialists treating patients with a diabetic foot ulcer, and the third is aimed at clinical researchers. Three consensus groups were formed and each had a chairperson who communicated with the editorial board, who were responsible for the communication with the members of the IWGDF. The members of each group were representatives of the IWGDF or wellknown experts in the field; in addition, the classification

group included the researchers who had developed an ulcer classification scheme in the past. During the consensus process the same procedures were followed as described earlier. Each group was asked to produce a text that was in line with the International Consensus of 1999 and with other related consensus projects, such as the TransAtlantic InterSociety Consensus group on peripheral arterial disease and the Infectious Disease Society of America, which was in the process of formulating guidelines on foot infections in diabetic patients. First the topics and the agenda were chosen, and in collaboration with the editorial board preliminary texts were produced by the three working groups, and in this phase the chairperson of each group was in close contact with the editorial board. The texts were subsequently sent to all members of the IWGDF for comment, the editorial board edited the comments, and the new text was sent back to the chairperson of the working groups for their final comments. These last versions were discussed in depth during a meeting of the IWGDF in May 2003, in The Netherlands. During the consensus project on wound healing it became clear that, unfortunately, lack of evidence precluded the formulation of a consensus text. Therefore, a progress report was written that can serve as a starting point for a future consensus project. In this comprehensive and accurate review the rapidly growing field of wound biology is delineated, the barriers to healing in diabetes are defined, the basis for a rational management is described, and an agenda for future research is proposed. This consensus group will be asked by the editorial board to continue their activities with the aim to formulate, if possible, a consensus document in 2007. To date, more than 10 different systems have been developed to classify diabetic foot ulcers, but no system has found universal acceptance and different centers of excellence use different classification systems. This lack of uniformity clearly hampers comparison of different studies and impairs communication between researchers. Reaching consensus on this topic was clearly a challenge for all experts involved, but already early in the project consensus was reached on the backbone of a research classification system. In this PEDIS system, perfusion, extent/size, depth/tissue loss, infection, and sensation should be categorized in each patient. For each category a strict grading system was developed, and defining this grading system in unambiguous terms, which are applicable in clinical research, was the greatest challenge. At the 2003 meeting the final document was approved by all IWGDF members and external experts. The PEDIS system is intended for research. A system to categorize the risk for future ulceration was aready given in the Practical Guidelines and was validated in 2001 [19]. Because the PEDIS system has not been validated, it was decided that this validation should be performed first before the system could be endorsed and published as a consensus text by the IWGDF. The third document was a consensus text on the infected diabetic foot, and was approved by all IWGDF members

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with their signature. In this document the pathophysiology, clinical presentation, and microbiology of (infected) diabetic foot ulcers is described. Based on the present evidence the consensus group was able to provide a framework for diagnosing and treating patients with (suspected) diabetic foot infections. In the section on management, particular emphasis was placed on discussing the rationale of antibiotic treatment, which therapy is most appropriate, and which other options should be pursued. In a separate part, clear practical guidelines are provided that can serve as the basis for daily clinical management. All three documents were approved by the IWGDF in the meeting directly preceding the Fourth International Symposium on the Diabetic Foot, The Netherlands, May 2224, 2003. Subsequently, the results of the consensus projects were presented during this symposium, and were then distributed as an interactive CD-ROM to all participants. The document on foot infection is a consensus text that will also be published on behalf of the IWGDF in scientific journals. The texts on wound healing and classification are progress reports; in case the classification system is validated with favorable results, it will be published as a consensus text.

care throughout the world (60 countries) was recently completed and will be published soon. The aforementioned activities by the IDF Consultative Section on the Diabetic Foot and IWGDF will also support the production of a book in the series Time to act on the diabetic foot, which will be published in 2005 on the World Diabetes Day on Foot Care. Financial support is essential to enable this independent and nonprofit making program to function to its best potential. Until now, Johnson & Johnson, Dermagraft Joint Venture (Advanced Tissue Sciences, La Jolla, CA/Smith & Nephew, Memphis, TN), and the Dutch EASD Fund have donated generously, but more donations are needed for the implementation program. However, this rather unique and still ongoing project would not have been possible without the enthusiastic support of many individuals, because most of these activities have been performed in their free time, on weekends, and at night. This unconditional support by many different kinds of professionals, directly or indirectly involved in the care of diabetic patients with foot problems, was the basis of the success of the project.

Conclusions Implementation
Since the publication of the Consensus documents in 1999, many activities have been undertaken to support the implementation of the IWGDF guidelines worldwide. In 2001, the IWGDF was asked to become an official consultative section of the IDF, which facilitated the creation of a worldwide network. The Consensus documents resulted in several publications in (scientific) medical journals, publications in books, and representatives of the IWGDF have given trainings and lectures all over the world. National representatives were appointed to organize local meetings to implement the Consensus documents on a worldwide basis, and the original documents were produced in such a way that a speedy and relatively cheap translation is possible, with an identical layout of all translated documents. In 2003, the International Consensus was translated in 21 languages and six translations were in process. The IWGDF has representatives in 60 countries, and in many countries the translation of the Consensus documents or the Guidelines led to the launching of national implementation programs. This implementation process is a continuous one, and national representatives were invited to report their experiences at the IWGDF meeting in 2003. The interactive CD-ROM described earlier also contains the International Consensus Document (1999), the Practical Guidelines on the Management and Prevention of the Diabetic Foot (1999) in English, French, and Spanish, and a picture gallery for teaching purposes. An IWGDF survey on the status of foot Although much has been learned on the prevalence, pathogenesis, and socioeconomic factors of diabetic foot problems in recent decades, the current evidence base for the prevention and treatment is relatively meager. A multifactorial approach, in which all relevant professionals are involved, is essential for formulating a common language, a common diagnostic approach, and optimal management. The International Consensus on the Diabetic Foot is a rather unique and very successful initiative, which succeeded in reaching these very ambitious goals with the worldwide input of many different specialists who were willing to share knowledge and experience without restrictions and to spend many hours without any compensation. Also, the early emphasis on implementation and the creation of an active worldwide network probably contributed to its success.

Editors Note
Copies of the Consensus Document (1999) and the interactive CD-ROM (2003) can be obtained at the IDF Office, Brussels, Belgium: http://www.idf.org/home/ i n d e x . c f m ? u n o d e = 1 9 AC E 4 3 7 - 9 B B 9 - 4 B 1 3 - B 2 A 9 D632EF80C2DA. Information about the IDF Consultative Section on the Diabetic Foot and the International Working Group on the Diabetic Foot can be obtained from the web site http://www.diabetic-foot-consensus.com or by e-mail at karel.bakker@hetnet.nl.

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References and Recommended Reading


Papers of particular interest, published recently, have been highlighted as: Of importance Of major importance
1. The International Working Group on the Diabetic Foot, ed: International Consensus on the Diabetic Foot. Maastricht, Netherlands: The International Working Group on the Diabetic Foot; 1999. This booklet gives an overview on the socioeconomic factors, diagnosis, and treatment based on the input of many different specialists worldwide. 2. Apelqvist J, Larsson J: What is the most effective way to reduce amputations in the diabetic foot? Diabetes Metab Res Rev 2000, 16(suppl 1):S75S83. 3. Brod M: Quality of life issues in patients with diabetes and lower extremity ulcers: patients and care givers. Qual Life Res 1998, 7:365372. 4. Apelqvist J, Ragnarson-Tennvall G, Larsson J, Persson U: Longterm costs for foot ulcers in diabetic patients in a multidisciplinary setting. Foot Ankle Int 1995, 16:388394. 5. Ramsey SD, Newton K, Blough D, et al.: Incidence, outcomes, and cost of foot ulcers in patients with diabetes. Diabetes Care 1999, 22:382387. 6. Ollendorf DA, Kotsanos JG, Wishner WJ, et al.: Potential economic benefits of lower-extremity amputation prevention strategies in diabetes. Diabetes Care 1998, 21:12401245. 7. Boulton AJ: The diabetic foot: a global view. Diabetes Metab Res Rev 2000, 16(suppl 1):S2S5. 8. Reiber GE, Vileikyte L, Boyko EJ, et al.: Causal pathways for incident lower-extremity ulcers in patients with diabetes from two settings. Diabetes Care 1999, 22:157162. In treating patients, an understanding of the pathogenesis as described in this article is necessary.

9. Jeffcoate WJ, Harding KG: Diabetic foot ulcers. Lancet 2003, 361:15451551. A recent article giving a clear and succinct overview of diabetic foot ulcers. 10. Mason J, O'Keeffe C, Hutchinson A, et al.: A systematic review of foot ulcer in patients with type 2 diabetes mellitus. II: treatment. Diabet Med 1999, 16:889909. 11. Edmonds ME, Blundell MP, Morris ME, et al.: Improved survival of the diabetic foot: the role of a specialized foot clinic. Q J Med 1986, 60:763771. 12. Dargis V, Pantelejeva O, Jonushaite A, et al.: Benefits of a multidisciplinary approach in the management of recurrent diabetic foot ulceration in Lithuania: a prospective study. Diabetes Care 1999, 22:14281431. 13. Holstein P, Ellitsgaard N, Olsen BB, Ellitsgaard V: Decreasing incidence of major amputations in people with diabetes. Diabetologia 2000, 43:844847. 14. Chaturvedi N, Stevens LK, Fuller JH, et al.: Risk factors, ethnic differences and mortality associated with lower-extremity gangrene and amputation in diabetes. The WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia 2001, 44(suppl 2):S65S71. 15. Larsson J, Apelqvist J: Towards less amputations in diabetic patients. Incidence, causes, cost, treatment, and prevention: a review. Acta Orthop Scand 1995, 66:181192. 16. van Houtum WH, Lavery LA: Methodological issues affect variability in reported incidence of lower extremity amputations due to diabetes. Diabetes Res Clin Pract 1977, 38:177183. 17. Frykberg RG, Piaggesi A, Donaghue VM, et al.: Difference in treatment of foot ulcerations in Boston, USA and Pisa, Italy. Diabetes Res Clin Pract 1997, 35:2126. 18. Apelqvist J, Bakker K, van Houtum WH, et al.: International consensus and practical guidelines on the management and the prevention of the diabetic foot. International Working Group on the Diabetic Foot. Diabetes Metab Res Rev 2000, 16(suppl 1):S84S92. 19. Peters EJ, Lavery LA: Effectiveness of the diabetic foot risk classification system of the International Working Group on the Diabetic Foot. Diabetes Care 2001, 24:14421447.

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