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Quá trình lành thương Tạp chí y khoa Quá trình lành thương Journal vol12no3102012 Organisation in wound healing
ORGANISATION IN WOUND HEALING Danish Wound Healing Society FOCUS ON Volume 12 Number 3 October 2012 Published by European Wound Management Association Ann-Mari Fagerdahl EWMA Council The EWMA Journal ISSN number: 1609-2759 Volume 12, No 3, October, 2012 The Journal of the European Wound Management Association Published twice a year Editorial Board Sue Bale, UK, Editor Jan Apelqvist, Sweden Martin Koschnick, Germany Marco Romanelli, Italy Rytis Rimdeika, Lithuania José Verdú Soriano, Spain Rita Gaspar Videira, Portugal Salla Seppänen, Finland EWMA web site www.ewma.org Editorial Office please contact: EWMA Secretariat Nordre Fasanvej 113 2000 Frederiksberg, Denmark Tel: (+45) 7020 0305 Fax: (+45) 7020 0315 ewma@ewma.org Layout: Birgitte Clematide Printed by: CS Grafisk A/S, Denmark Copies printed: 9000 Prices: The EWMA Journal is distributed in hard copies to members as part of their EWMA membership. EWMA also shares the vision of an “open access” philosophy, which means that the journal is freely available online. Individual subscription per issue: 7.50€ Libraries and institutions per issue: 25€ The next issue will be published in April 2013. Prospective material for publication must be with the editors as soon as possible and no later than January 15th 2013. The contents of articles and letters in EWMA Journal do not necessarily reflect the opinions of the Editors or the European Wound Management Association. All scientific articles are peer reviewed by EWMA Scientific Review Panel. Copyright of published material and illustrations is the property of the European Wound Management Association. However, provided prior written consent for their reproduction, including parallel publishing (e.g. via repository), obtained from EWMA via the Editorial Board of the Journal, and proper acknowledgement, such permission will normally be readily granted. Requests to reproduce material should state where material is to be published, and, if it is abstracted, summarised, or abbreviated, then the proposed new text should be sent to the EWMA Journal Editor for final approval. All issues of EWMA Journal are CINAHL listed. CO-OPERATING ORGANISATIONS’ BOARD Christian Thyse, AFISCeP.be Tommaso Bianchi, AISLeC Roberto Cassino, AIUC Aníbal Justiniano, APTFeridas Gerald Zöch, AWA Jan Vandeputte, BEFEWO Vladislav Hristov, BWA Els Jonckheere, CNC Lenka Veverková, CSLR Nastja Kucišec-Tepeš, CWA Arne Buss, DGfW Bo Jørgensen, DSFS Anna Hjerppe, FWCS Pedro Pacheco, GAIF J. Javier Soldevilla, GNEAUPP Christian Münter, ICW Aleksandra Kuspelo, LBAA Susan Knight, LUF Loreta Pilipaityte, LWMA Corinne Ward, MASC Hunyadi János, MSKT Suzana Nikolovska, MWMA Anne Wilson, NATVNS Kristin Bergersen, NIFS Louk van Doorn, NOVW Arkadiusz Jawie´n, PWMA Severin Läuchli, SAfW (DE) Hubert Vuagnat, SAfW (FR) Goran D. Lazovic, SAWMA Mária Hok, SEBINKO F. Xavier Santos Heredero, SEHER Sylvie Meaume, SFFPC Susanne Dufva, SSIS Jozefa Košková, SSOOR Leonid Rubanov, STW (Belarus) Guðbjörg Pálsdóttir, SUMS Cedomir Vucetic, SWHS Serbia Magnus Löndahl, SWHS Sweden Alison Hopkins, TVS Jasmina Begi´c-Rahi´c, URuBiH Zoya Ishkova, UWTO Barbara E. den Boogert-Ruimschotel, V&VN Julie Jordan O’Brien, WMAI Skender Zatriqi, WMAK Nada Kecelj Leskovec, WMAS Mustafa Deveci, WMAT Paulo Jorge Pereira Alves, Portugal Caroline Amery, UK Jan Apelqvist, Sweden Sue Bale, UK Michelle Briggs, UK Stephen Britland, UK Mark Collier, UK Rose Cooper, UK Javorka Delic, Serbia Corrado Maria Durante, Italy Bulent Erdogan, Turkey Ann-Mari Fagerdahl, Sweden Madeleine Flanagan, UK Milada Francu˚, Czech Republic Peter Franks, UK Francisco P. García-Fernández, Spain Magdalena Annersten Gershater, Sweden Georgina Gethin, Ireland Luc Gryson, Belgium Eskild W. Henneberg, Denmark Alison Hopkins, UK Gabriela Hösl, Austria Dubravko Huljev, Croatia Gerrolt Jukema, Netherlands Nada Kecelj, Slovenia Klaus Kirketerp-Møller, Denmark Zoltán Kökény, Hungary Martin Koschnick, Germany Severin Läuchli, Schwitzerland Maarten J. Lubbers, Netherlands Sylvie Meaume, France Zena Moore, UK EWMA JOURNAL SCIENTIFIC REVIEW PANEL Magdalena Anner- sten Gershater Jan Apelqvist President Zena Moore Immediate Past President Mark Collier Barbara E. den Boogert-Ruimschotel Paulo Alves Javorka Delic Salla Seppänen President Elect Robert StrohalRytis Rimdeika Elia Ricci José Verdú SorianoSebastian Probst Gerrolt Jukema Scientific Recorder Corrado M. Durante Treasurer Dubravko Huljev Secretary Martin Koschnick Nada Kecelj-Leskovec Georgina Gethin Christian Münter, Germany Andrea Nelson, UK Pedro L. Pancorbo-Hidalgo, Spain Hugo Partsch, Austria Patricia Price, UK Sebastian Probst, Schwitzerland Elia Ricci, Italy Rytis Rimdeika, Lithuania Zbigniew Rybak, Poland Salla Seppänen, Finland José Verdú Soriano, Spain Robert Strohal, Austria Richard White, UK Carolyn Wyndham-White, Switzerland Gerald Zöch, Austria Sue Bale EWMA Journal Editor 2 Science, Practice and Education Organisations Cochrane Reviews EWMA C O O P E R A T I O N I N C O P E N H A G E N O R G A N I S A T I O N A N D WWW.EWMA.ORG / EWMA2013 23 rd Conference of the European Wound Management Association EWMA 2013 15 - 17 May · 2013 · Copenhagen · Denmark Organised by the European Wound Management Association in cooperation with the Danish Wound Healing Society · www.saar.dk A b s t r a c t d e a d l i n e : 1 J a n u a r y 2 0 1 3 5 Editorial 6 Therapeutic strategies for diabetic foot ulceration RJ Hinchliffe, JRW Brownrigg 13 Offloading the diabetic foot: Evidence and clinical decision making S.A. Bus 17 Soft-tissue complications during treatment of children with congenital clubfoot A. Baindurashvili, V. Kenis, Y. Stepanova 21 An evolution in Medical Tapes: From Latex to Acrylic L. Gryson 27 Bacteria and fungus binding mesh in negative pressure wound therapy – A review of the biological effects in the wound bed M. Malmsjö, S. Lindstedt, R. Ingemansson, L. Gustafsson 33 Conservative Sharp Wound Debridement – State of play in Australia J. C. Rice 40 Abstracts of recent cochrane reviews S. Bell-Syer 42 EWMA Journal Previous Issues an Other Journals 44 EWMA 2012 in Vienna G. Zöch, G. Jukema 48 DSFS – What can we do? What will we do? J. Fonnesbech 52 The Cooperating Organisations Board Meeting 2012, Vienna Z. Moore 54 The Austrian Diabetic Foot Symposium G. Köhler 58 Symposium for russian speakers at EWMA 2012 Vienna R. Rimdeika 61 EWMA UCM experience, Vienna 2012 – An evaluation B. Ø. Melby, S. Wichmann 64 The UCM in Switzerland: Development and prospects L. Chabal, C. Wyndham-White 66 EWMA News 68 The EWMA Teacher Network – a report Zena Moore 70 The EWMA Patient Panel S. Seppänen 73 Advocacy for better wound management in Europe J. Apelqvist 74 EUCOMED – Outlook and programmes for wound care in UK and USA H. Lundgren 76 EWMA Corporate sponsors 77 Conference Calendar 78 AAWC – Association for the Advancement of Wound Care R. J. Snyder 80 SEHER – The Spanish Society of Wounds X. S. Heredero 82 UWTO– Ukrainian Wound Treatment Organisation G. Kozinets, Z. Ishkova 84 SILAUHE – Iberolatino american Society of Ulcers and Wounds M. Blanck, J. J. Soldevilla 86 EWMA Cooperating Organisations 3 Embarrassed by visible strikethrough, worried by knocks and bumps, frustrated by dressings that refuse to stay in place; for people with chronic wounds, hiding at home can feel like their only option. At Smith & Nephew our observational research revealed all the reasons why living with a chronic wound stops people living the life they want to lead. Designed for people. Designed for life. Bring your wound care patients out of hiding Wound Management Smith & Nephew Medical Ltd 101 Hessle Road Hull HU3 2BN UK T +44 (0) 1482 225181 F +44 (0) 1482 328326 ™Trademark of Smith & Nephew © Smith & Nephew June 2012 36340 The results inspired us to create ALLEVYN Life, a dressing specially designed to help people with chronic wounds regain their freedom, positively impacting on patient wellbeing. Find out how ALLEVYN Life can help you bring your patients out of hiding Visit: www.allevynlife.com 19992 S+N Allevyn Life Master A4 Ad.indd 1 31/07/2012 12:21 T his issue of the EWMA Journal fo- cuses on the host country of the EWMA 2013 Conference: Denmark. The Danish Wound Management Associa- tion presents its efforts to meet some of the challenges related to providing the best possible care for wound patients in hospitals as well as in the home care sector. Most of these challenges are related to the organisa- tional aspects of care. The Danish Wound Management Associa- tion was one of the first organisations to develop a model for multidisciplinary and intersectoral organisation of wound manage- ment. This model has become widely recognised throughout the world. Multidisci- plinary wound management centres have been widely implemented in Denmark, but there is still room for improvement; especially within the home care sector. Establishing efficient wound management is an on-going challenge all over Europe. EWMA is continuously looking for new ways to meet this challenge. Recently EWMA joined the European Innovation Partnership on Active and Healthy Ageing (AHAIP) established by the European Commission. EWMA uses this collaboration to advocate the importance of a multidisciplinary and integrated care for elderly people suffering from non healing wounds. You can read more about this initiative in this issue of the EWMA Journal. Another opportunity for securing specialised wound care throughout Europe is further utilisation of modern technologies. In recent years Denmark has moved towards greater use of e-health services. Telemedicine systems developed for wound management offer improved wound care in home care settings outside the most populated areas. This is expected to lead to a significant reduction in the cost of wound management within the Danish municipalities. This focus on organisation of care and collab- oration between various sectors has been a primary focus of the Danish organisation for many years, which made it the natural choice of theme and title for the EWMA 2013 Conference: Organisation and Cooperation in Copenhagen. This topic will be reflected in several activities during the conference, such as key sessions on e-health and multidiscipli- nary treatment, and sessions targeting home care nurses without specialisation in wound management. In this and the next issue of the EWMA Journal we will offer various articles leading up to the conference sessions and activities. We look forward to discussing these topics with you at the conference. Jan Apelqvist, EWMA President and Eskild Henneberg, DSFS President Wound management organisation – the on-going challenge in Europe EWMA J ournal 2012 vol 12 no 3 5 RJ Hinchliffe Senior Lecturer, Consultant in Vascular Surgery JRW Brownrigg NIHR Academic Clinical Fellow in Vascular Surgery St George’s Vascular Institute, St George’s Healthcare NHS Trust, London United Kingdom Correspondence: jrwbrownrigg@gmail.com Conflict of interest: none INTRODUCTION / EPIDEMIOLOGY The increasing worldwide prevalence of diabetes mellitus (DM) has resulted in an inevitable rise in diabetes-related complications. Diabetic foot ulceration (DFU) precedes >85% of major am- putations in patients with diabetes and despite evidence to suggest that targeted interventions resulting from multidisciplinary care can reduce limb loss, 1 progress to date has been slow. The National Diabetes Audit conducted in the UK estimates that the risk of a person with diabe- tes undergoing a lower extremity amputation is 23-fold higher than that of a person without diabetes. 2 Whilst the number and incidence of amputations have fallen in an ageing population without diabetes, those in patients with type 2 diabetes have risen. 3 In 2010-2011 there were 72,459 hospital admissions for diabetes-related foot complications, costing the National Health Service in England and Wales an estimated £639 million to £662 million. 4, 5 Observational data from the Eurodiale study of all patients presenting with DFU to 14 specialised foot centres in Europe suggests marked variation in patterns of referral, the use of casting and vas- cular assessment and intervention between cen- tres and countries. 6 Of concern is that gaps in the use of evidence-based therapies highlighted by Eurodiale are likely to be far wider outside of specialised centres. A lack of both multidiscipli- nary diabetic foot clinics and appropriate re-im- bursement schemes in many European countries are barriers to achieving good care. This review focuses on recent evidence-based guidelines, in particular those produced by the International Working Group on the Diabetic Foot (IWGDF), to help clinicians make treatment decisions in the management of DFU. PATHOLOGY IN DFU The aetiology of diabetic foot ulceration is multi- factorial, involving a complex interplay between distal polyneuropathy (motor, sensory and au- tonomic), microangiopathy and peripheral arte- rial disease (PAD). Ulceration typically follows abnormal loading or trauma of the neuropathic foot, which may be poorly perfused due to PAD, rendering it less able to heal. Wound repair may be further impaired by virtue of various biological factors inherent to diabetes, including impaired humoral immunity and abnormal inflammatory responses. 7, 8 Infection in DFU is more common than in other types of chronic wounds and con- tributes to failure to heal, especially in the pres- ence of PAD. 9 Diabetes is no longer considered an occlusive small vessel disease, but involves several functional abnormalities of the microvasculature including an increase in arterio-venous shunting and im- paired vasoreactivity. 10 The growth of new blood vessels in response to ischaemia is also impaired in DM, 11 resulting in reduced formation of collateral vessels and a more profound perfusion deficit. The distribution of PAD in patients with diabetes is characteristically distal and diffuse, with a greater prevalence of crural disease and long arterial oc- clusions. 12-14 EVALUATION There are robust data to demonstrate that multi- disciplinary care of patients with DFU reduces amputation rates. Guidance from the National Institute for Health and Clinical Excellence and Diabetes UK is consistent in recommending prompt recognition of foot ulceration and rapid assessment in a specialised limb salvage unit. 15, 16 Krishnan et al observed a 62% reduction in major amputations in a catchment general population following the introduction of a multidisciplinary foot team at Ipswich Hospital, UK. 1 Early inter- Therapeutic strategies for diabetic foot ulceration EWMA J ournal 2012 vol 12 no 3 6 Science, Practice and Education vention is critical given the difficulty in managing larger ulcers; in a study of 534 patients referred to a tertiary diabetic foot clinic with critical limb ischaemia (CLI) and a foot lesion, an ulcer area >5cm 2 predicted both failure to heal and amputation. 17 Peripheral arterial disease PAD is present in >50% of patients with DFU and its pres- ence must be excluded. Diagnosing PAD in patients with diabetes can be difficult as symptoms and signs are fre- quently masked by co-existing distal symmetrical polyneu- ropathy. Furthermore, most patients with DFU present to primary care or internal medicine clinicians or podiatrists who often lack expertise in the diagnosis of PAD. IWGDF guidelines recommend that, in addition to a thorough history for symptoms of arterial insufficiency, all patients with DFU should undergo hand-held Doppler evaluation of both pedal pulses, measurement of ankle-brachial index (ABI) and, in cases of diagnostic uncertainty, measurement of toe-brachial index (TBI). 18 Once PAD is diagnosed, the severity of the perfusion deficit and its impact on ulcer healing should be assessed. With respect to ankle pressures, an ABI of <0.6 corresponds to a significant impairment in wound healing (Figure 1), 19 and an ABI of >0.6 has a poor predictive value for severity of ischaemia and war- rants the measurement of toe pressures. A low probability of wound healing due to poor perfusion should prompt further investigations to establish the distribution of PAD. Duplex ultrasonography (DUS), magnetic resonance angi- ography (MRA) and computed tomography angiography (CTA) all enable imaging of the lower-limb arteries in a non-invasive manner and each technique has its advan- tages and drawbacks. DUS and MRA avoid the need for iodinated contrast, which can be problematic in patients with diabetes and a high prevalence of diabetic nephropa- thy. CTA is faster and more comfortable for patients than MRA, although image interference from calcified arteries can make interpretation difficult. Digital subtraction an- giography remains the gold standard imaging modality for evaluating the distribution of PAD when revascularisation is planned and has the advantage of allowing simultaneous endovascular intervention. Its main drawback is the risk of contrast-induced nephropathy. The decision to revascularise the ulcerated foot is com- plex. Multiple factors influence wound healing in diabe- tes and only those patients with a perfusion deficit will derive any benefit from revascularisation. Patients with mild PAD and adequate perfusion measurements (ABI 0.6, TcPO 2 >50mmHg) should be initially managed with optimal wound care and a 6-week period of observation. 20 In large ulcers and in those with infection, the expected outcome of conservative treatment is poor and earlier vas- cular intervention may be required. In cases where PAD is contributing towards impaired wound healing then all ambulatory patients should be considered for revas- Figure 1. Schematic estimate of the probability of healing of foot ulcers and minor amputations in relation to ankle blood pressure, toe blood pressure, and transcutaneous oxygen pressure (TcPo2) based on selected reports. From Apelqvist J, Bakker K, van Houtum WH, Schaper NC. Practical guidelines on the management and prevention of the diabetic foot. Diabetes Metab Res Rev 2008;24:S181- S187. References 1. Krishnan S, Nash F, Baker N, Fowler D, Rayman G. Reduction in diabetic amputa- tions over 11 years in a defined UK population: benefits of multidisciplinary work and continuous prospective audit. Diabetes Care 2008;31:99-101. 2. Vamos EP, Bottle A, Edmonds ME, Valabhji J, Majeed A, Millett C. Changes in incidence of lower extremity amputations in individuals with and without diabetes in England between 2004 and 2008. Diabetes care 2010;33:2592-2597 3. National Diabetes Audit Executive Summary 2009-10 The NHS Information Centre 2011 4. Holman N, Young RJ, Jeffcoate WJ. Variation in the recorded incidence of amputa- tion of the lower limb in England. Diabetologia 2012;55:1919-25. 5. Kerr M. Foot care in diabetes: the economic case for change. www.diabetes.nhs.uk/ document.php?o=3400. 6. Prompers L, Huijberts M, Apelqvist J, et al. Delivery of care to diabetic patients with foot ulcers in daily practice: results of the Eurodiale Study, a prospective cohort study. Diabet Med 2008;25:700-707. 7. Martin JM, Zenilman JM, Lazarus GS. Molecular microbiology: new dimensions for cutaneous biology and wound healing. J Investig Dermatol 2010;130:38-48. 8. Blakytny R, Jude E. The molecular biology of chronic wounds and delayed healing in diabetes. Diabet Med 2006;23:594-608. 9. Prompers L, Schaper N, Apelqvist J, et al. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The Eurodiale Study. Diabetologia 2008;51:747-755. 10. Abularrage CJ, Sidawy AN, Aidinian G, Singh N, Weiswasser JM, Arora S. Evaluation of the microcirculation in vascular disease. J Vasc Surg 2005;42:574-81. 11. Abaci A, Oguzhan A, Kahraman S, et al. Effect of diabetes mellitus on formation of coronary collateral vessels. Circulation 1999; 99: 2239±2242. 12. LoGerfo FW, Conrad MC. Large and small artery occlusion in diabetics and nondiabetics with severe vascular disease. Circulation 1967;36:83-91. 13. Faglia E, Favales F, Quarantiello A, et al. Angiographic evaluation of peripheral arte- rial occlusive disease and its role as a prognostic determinant for major amputation in diabetic subjects with foot ulcers. Diabetes Care 1998;21:625-630. 14. Jude EB, Oyibo SO, Chalmers N, Boulton AJ. Peripheral arterial disease in diabetic and nondiabetic patients: a comparison of severity and outcome. Diabetes Care 2001;24: 1433-1437. EWMA J ournal 2012 vol 12 no 3 7 cularisation, with the exception of the severely frail (life expectancy <6 months), the functionally impaired, those with an unsalvageable foot or those where the ulcer is not impairing quality of life. ULCER/ WOUND MANAGEMENT There are several simple yet important principles of wound bed management, which should be adhered to in DFU. Regular inspection, cleaning with saline, removal of sur- face debris with sharp debridement and protection of regenerating tissue are paramount. Controlling exudate to maintain a moist environment can be achieved with a simple, inert dressing in most cases. 21 The evidence to support the use of a particular dressing or topical therapy for the ulcer bed is thin. Providing a comprehensive envi- ronment to improve healing with debridement, offloading and antibiotics in the presence of infection is superior to the use of a novel, and often expensive, dressing. Offloading Biomechanical factors play an important role in the aeti- ology of DFU and the cornerstone of early management in neuropathic plantar ulcers is offloading pressure with appropriate footwear, removable devices or total contact casts (TCCs). The efficacy of prescribed footwear and re- movable devices is dependent on patient compliance and, probably for this reason, the TCC has demonstrated supe- rior results in randomised trials, 22 and is recommended by the IWGDF as first-choice treatment. 23 A perception of increased risk of falls with TCCs appears to be unfound- ed. 24, 25 Despite all this, only 18% of approximately 600 patients with a plantar foot ulcer in the Eurodiale study were treated with TCCs. 6 Callus formation contributes to abnormal loading and failure to heal, and debridement should be routinely provided by trained podiatrists. Deb- ridement is beneficial for reducing plantar pressures, 26, 27 although this has yet to be confirmed in randomised trials. Dressings/ Topical therapies Despite their widespread use, the quality of published reports supporting the application of topical therapies in DFU is poor. The IWGDF and a Cochrane review identi- fied no good quality randomised controlled trials (RCTs) reporting healing outcomes from which to produce clini- cal guidelines. 28, 29 Bioengineered skin grafts have dem- onstrated favorable results in a prospective RCT involv- ing more than 300 patients receiving a dermal fibroblast culture 30 A greater proportion of patients receiving the bioengineered skin achieved complete healing at 12 weeks (30% vs 18%), however the healing rates in the control group were lower than expected. Although negative pressure wound therapy (NPWT) has been extensively adopted in the treatment of chronic wounds, much of the supporting evidence is based on industry-funded trials. More than half of studies have not been reported and unpublished data are largely inac- cessible. 31 One well-designed, industry supported RCT of 342 patients with an ulcer >2cm 2 reported promising outcomes. 32 NPWT was associated with reduced time to wound closure, increased incidence of healing by 16 weeks and reduced incidence of minor amputation. Fur- ther study is, however, needed to justify the use of NPWT in routine clinical practice. A marked benefit in terms of healing is unlikely given most wounds take months to heal and NPWT is only applied for a short period of time. Hyperbaric oxygen therapy (HBO) has also been used with limited supporting evidence. Two double-blinded RCTs have provided stronger justification for HBO in selected patients although issues of cost-effectiveness, patient selec- tion and timing of treatment remain. The larger of the RCTs involved patients with either no evidence of PAD or unreconstructable disease and demonstrated significantly improved ulcer healing at 12 months in the intervention group: 25/48 (52%) versus 12/42 (27%); p=0.03. 33 15. National Institute for Health and Clinical Excellence. Diabetic Foot Problems: Inpatient Management of Diabetic Foot Problems. Clinical guideline 119. 2011:http://guidance.nice.org.uk/GC119 [accessed14 August 2012]. 16. Diabetes UK. Putting Feet First: Commissioning Specialist Services for the Manage- ment and Prevention of Diabetic Foot Disease in Hospitals. www.diabetes.org.uk/ Documents/Reports/Putting_Feet_First_010709.pdf [accessed14 August 2012].17. Uccioli L, Gandini R, Giurato L, et al. Long-term outcomes of diabetic patients with critical limb ischaemia followed in a tertiary referral diabetic foot clinic. Diabetes Care 2010;977-982. 18. Schaper NC, Andros G, Apelqvist J, et al. Specific guidelines for the diagnosis and treatment of peripheral arterial disease in a patient with diabetes and ulceration of the foot, 2011. Diabetes Metab Res Rev 2012; 28:236-237. 19. Apelqvist J, Bakker K, van Houtum WH, Schaper NC. Practical guidelines on the management and prevention of the diabetic foot. Diabetes Metab Res Rev 2008;24:S181-S187. 20. Sheehan P, Jones P, Caselli A, Giurini JM, Veves A. Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-weel prospective trial. Diabetes Care 2003;26:1879-1882. 21. Game FL, Hinchliffe RJ, Apelqvist J, et al. Specific guidelines on wound and wound-bed management 2011. Diabetes Metab Res Rev 2012;28(S1):232-233. 22. Armstrong DG, Nguyen HC, Lavery et al. Offloading the diabetic foot: a randomised clinical trial. Diabetes Care 2001;24:1019-1021. 23. Bus SA, Valk GD, van Deursen RW, et al. The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a systematic review. Diabetes Metab Res Rev 2008;24(S1):162-180. 24. Armstrong DG, Nguyen HC, Lavery LA, van Schie CHM, Boulton AJM, Harkless LB. Off-loading the diabetic foot wound. A randomised clinical trial. Diabetes Care 2001;24(6):1019-1022. 25. Armstrong DG, Lavery LA, Wu S, Boulton AJM. Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds. A randomised controlled trial. Diabetes Care 2005;28(3):551-554. 26. Pitei DL, Foster A, Edmonds M. The effect of regular callus removal on foot pressures. J Foot Ankle Surg 1999;38:251-255. 27. Young MJ, Cavanagh PR, Thomas G, Johnson MM, Murray H, Boulton AJ. The effect of callus removal on dynamic plantar foot pressures in diabetic patients. Diabet Med 1992;9:55-57. EWMA J ournal 2012 vol 12 no 3 8 Science, Practice and Education MEDICAL MANAGEMENT Infection / antibiotics Infection of a foot ulcer represents a major threat to limb and life and must be recognised and treated promptly. The diagnosis of diabetic foot infection is based on clini- cal findings; superficial wound cultures are not useful and should not be treated, as bacterial colonisation appears to be ubiquitous in DFU. Infection may spread to involve underlying bone in around a fifth of cases (osteomyelitis), which is associated with a worse outcome. Bone biopsy for histopathology and culture remains the “gold standard” for diagnosing osteomyelitis, however, this procedure is not routinely performed in clinical practice. 34 Results from both histopathology and culture may be misleading where appropriate expertise is not available. The IWGDF has produced guidelines for the diagnosis and treatment of diabetic foot infections based on the severity of infection. 19 Ulcers with superficial infection should be treated with debridement and oral antibiotics aimed at Staphylococcus aureus and streptococci. Tar- geted therapy against gram +ve cocci has been shown to be equally effective as broader spectrum regimens, 35 even in the presence of osteomyelitis, which will respond to antibiotics in most cases. Deep infection, characterised by purulent discharge or fullness in the plantar space 36 necessitates urgent debridement of necrotic tissue in- cluding infected bone, and revascularisation if indicated. Intravenous broad-spectrum antibiotics should target Gram-positive and negative microorganisms, including anaerobes. Signs of life and limb threatening infection include bullae, ecchymoses, soft tissue crepitus and rapid spread of infection. 37 In the Eurodiale cohort, investigators observed a markedly negative impact of infection on ulcer healing that was confined to patients with PAD. These findings emphasise the need for studies evaluating the effects of early revascu- larisation on control of infection and different antibiotic regimens in PAD. 9 Modifying cardiovascular risk DM is recognised as a key risk factor for the development of cardiovascular disease (CVD) and mortality from CV causes is » 2-fold higher compared with individuals with- out DM. 38 A recent meta-analysis suggests that a history of DFU may increase this risk still further, reporting ex- cess all-cause mortality compared to patients with diabetes but without a history of DFU. 39 A report by Young et al suggests this excess risk in DFU can be attenuated by intensive CVD risk modification. 40 In a foot clinic popula- tion, five year mortality fell from 48% to 27% following introduction of a protocol incorporating CV risk screen- ing and administration of an antiplatelet agent, statin and antihypertensive where indicated. VASCULAR INTERVENTION The importance of a multidisciplinary decision involving clinicians offering expertise in revascularisation cannot be underestimated. Revascularisation in patients with dia- betes can be technically difficult by virtue of the distal distribution of disease, impaired collateral formation and vessel calcification. Data pooled by the IWGDF from 19 studies of patients with DFU and PAD showed a median limb salvage rate of 85% at one year. 41 Half of patients with DFU and PAD can expect to be alive at five years and mortality rises to 50% in two years following a major amputation. 42 Patients with co-existing chronic kidney disease (CKD) fare worse and the severity of CKD has been shown to correspond with poor outcomes and mor- tality following revascularisation. 43 There are no scoring systems which reliably predict outcome in patients with DFU and PAD undergoing revascularisation procedures. 28. Bergin S, Wraight P. Silver based wound dressings and topical agents for treating diabetic foot ulcers. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD005082. DOI: 10.1002/14651858.CD005082.pub2. 29. Hinchliffe RJ, Valk GD, Apelqvist J, et al. A systematic review of the effectiveness of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev 2008;24:S119-S144. 30. Marston WA, Hanft J, Norwood P, Pollak R. The efficacy and safety of dermagraft in improving the healing of chronic diabetic foot ulcers. Results of a prospective randomised trial. Diabetes Care 2003;26:1701-1705. 31. Pienemann F, McGauran N, Sauerland S, Lange S. Negative pressure wound therapy: potential publication bias caused by lack of access to unpublished study results data. BMC Med Res Methodol;8:4. 32. Blume PA, Walters J, Payne W, Ayala J, Lantis J. Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers. Diabetes Care 2008;31:631-636. 33. Londahl M, Katzman P, Nilsson A, Hammarlund C. Hyperbaric oxygen therapy facilitates healing of chronic foot ulcers in patients with diabetes. Diabetes Care 2010;33:998-1003. 34. Lipsky BA, Peters EJG, Senneville E, et al. Expert opinion on the management of infections in the diabetic foot. Diabetes Metab Res Rev 2012;28:163-178. 35. Lipsky BA, Itani K, Norden C. Treating foot infections in diabetic patients: a randomised, multicenter, open-label trial of linezolid versus ampicillin sulbactam/ amoxicillin-clavulanate. Clin Infect Dis 2004; 38: 17–24. 36. Boulton AJ, Meneses P, Ennis WJ. Diabetic foot ulcers: a framework for prevention and care. Wound Repair Regen 1999;7:7-16. 37. Eneroth M, Larsson J, Apelqvist J. Deep foot infections in patients with diabetes and foot ulcer: an entity with different characteristics, treatments, and prognosis. J Diabetes Complications 2000;13:254-63. 38. Preis SR, Hwang SJ, Coady S, et al. Trends in all-cause and cardiovascular disease mortality among women and men with and without diabetes mellitus in the Framingham Heart Study, 1950 to 2005. Circulation. 2009;119: 1728–1725. 39. Brownrigg JRW, Davey J, Holt PJ, et al. The association of ulceration of the foot with cardiovascular and all-cause mortality in patients with diabetes: a meta-analysis. Diabetologia. 2012 (Epub ahead of print) 40. Young MJ, McCardle JE, Randall LE, Barclay JI. Improved survival of diabetic foot ulcer patients 1995-2008. Possible impact of aggressive cardiovascular risk management. Diabetes Care 2008;31:2143-2147. EWMA J ournal 2012 vol 12 no 3 9 There are no randomised trial data comparing surgical bypass and endovascular techniques in selected patients with diabetes, however, in patients with diabetes and an ischaemic foot ulcer, these techniques appear to offer equivalent outcomes where revascularisation is success- ful. 44, 45 Endovascular techniques performed under lo- cal anaesthesia are lower-risk than bypass surgery, cost considerably less and are an appropriate initial approach to restoring perfusion. Surgical bypass has the advantage of increased durability when autologous vein is used but patients with multiple comorbidities and a short life ex- pectancy (6-12 months) are unlikely to realise this benefit. PREVENTION Foot examination focusing on the presence of peripheral neuropathy, PAD and abnormal foot anatomy can predict risk of developing a diabetic foot ulcer. 46, 47 In the UK, screening for foot disease in diabetes is undertaken by primary care physicians who stratify patients with diabetes according to their risk of ulceration. Evidence to sup- port the effectiveness of such screening programmes and complex interventions (education, podiatry, orthoses) in reducing both the risk of foot ulceration and mortality is still lacking. 48, 49 CLASSIFICATION AND OUTCOMES (REPORTING) Interpreting studies evaluating healing in DFU is made difficult by poor classification of PAD and ulcer char- acteristics. The Wagner classification should be avoided and more recent systems used (The University of Texas Wound classification system or the Size (Area and Depth), Sepsis, Arteriopathy, and Denervation score). 50, 51 A uni- versal classification system of diabetic foot ulcers would enable consistent reporting among studies to guide the development of novel therapies. To this end, the Euro- pean Wound Management Association (EMWA) has produced a set of recommendations for standardised re- porting of outcomes in studies of wound management, 52 which would enhance the external validity of research in this field and allow fair comparison between centres. Trial outcomes in DFU should include ulcer healing, which has been shown to be of particular importance to patients with diabetes. Patients with active ulceration report poorer health-related quality of life than those who have under- gone successful minor lower extremity amputation. 53 The balance of risk and benefit for interventions in diabetic foot disease is probably best assessed through a combina- tion of endpoints including mortality, amputation, healing and re-ulceration. CONCLUSIONS Studies evaluating the effectiveness of therapies in DFU are of mostly poor methodological quality in part because of the complexity of disease and inherent problems with study design. The Eurodiale study has highlighted gaps between current clinical practice and the best available evidence for treatment. To achieve improved outcomes with respect to healing, amputation and mortality, treat- ment in primary care and hospital settings should aim to adhere to the available guidelines. Particular emphasis should be placed on early recognition of DFU and rapid assessment by a specialized limb salvage team. m 41. Hinchliffe RJ, Andros G, Apelqvist J, et al. A systematic review of the effectiveness of revascularisation of the ulcerated foot in patients with diabetes and peripheral arterial disease. Diabetes Metab Res Rev 2012;28:179-217. 42. Moulik PK, Mtonga R, Gill GV. Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care 2003;26:491-494. 43. Owens CD, Ho KJ, Kim S, Schanzer A, Lin J, Matros E. Refinement of survival prediction in patients undergoing lower extremity bypass surgery: stratification by chronic kidney disease classification. J Vasc Surg 2007;45:944-52. 44. Albers M, Romiti M, Brochado-Neto FC, De Luccia N, Pereira CA. Meta-analysis of popliteal-to-distal vein bypass grafts for critical ischaemia: revised version. J Vasc Surg 1997;26:517-538. 45. Romiti M, Albers M, Brochado-Neto FC, Durrazo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischaemia. J Vasc Surg 2006;43:498-503 46. Abbott CA, Carrington AL, Ashe H, et al: The North-West Diabetes Foot Care Study: incidence of, and risk factors for, new diabetic foot ulceration in a community-based patient cohort. Diabet Med 2002;19:377–384, 2002. 47. Monteiro-Soares M, Boyko EJ, Ribiero J, Ribiero I, Dinis-Ribiero M. Risk stratification systems for diabetic foot ulcers: a systematic review. Diabetologia 2011;54:1190-1199. 48. Jeffcoate WJ. Stratification of foot risk predicts the incidence of new foot disease, but do we yet know that the adoption of routine screening reduces it? Diabetologia 2011;54:991-993. 49. Dorresteijn JAN, Kriegsman DMW, Valk GD. Complex interventions for preventing diabetic foot ulceration. Cochrane Database of Systematic Reviews 2010, Issue 1. Art. No.: CD007610. DOI: 10.1002/14651858.CD007610.pub2. 50. Macfarlane RM, Jeffcoate WJ. Classification of diabetic foot ulcers. The S(AD) SAD system. Diabetic Foot 1999;2:123-131. Lavery LA, Armstrong DG, Harkless LB. Classification of diabetic foot wounds. J Foot Ankle Surg 1996;35:528-31. 51. Armstrong DG, Lavery LA, Harkless LB: Validation of a diabetic wound classification system: the contribution of depth, infection, ischemia to risk of amputation. Diabetes Care 1998;21:855–859. 52. Gottrup F, Apelqvist J, Price P. Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management. JWC 2010;19:237-68. 53. Hogg FRA, Peach G, Price P, Thompson MM, Hinchliffe RJ. Measures of health- related quality of life in diabetes-related foot disease: a systematic review. Diabetolo- gia 2012;55:552-565. Science, Practice and Education EWMA J ournal 2012 vol 12 no 3 10 . multidisciplinary and integrated care for elderly people suffering from non healing wounds. You can read more about this initiative in this issue of the EWMA Journal. . ORGANISATION IN WOUND HEALING Danish Wound Healing Society FOCUS ON Volume 12 Number 3 October 2012 Published by European Wound Management