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Predictors of Lower-Extremity Amputation in Patients with An 852 Diabetes Care Volume 38, May 2015 Predictors of Lower-Extremity Kristy Pickwell,1 Volkert Siersma,2 Marleen Kars,1 Jan Apelqvist,3 Amputation in Patients With an Karel Bakker,4 Michael Edmonds,5 Per Holstein,6 Alexandra Jirkovska,´ 7 Infected Diabetic Foot Ulcer Edward Jude,8 Didac Mauricio,9 Alberto Piaggesi,10 Gunnel Ragnarson 11 12 Diabetes Care 2015;38:852–857 | DOI: 10.2337/dc14-1598 Tennvall, Heinrich Reike, Maximilian Spraul,13 Luigi Uccioli,14 Vilma Urbancic,15 Kristien van Acker,16 Jeff van Baal,17 and Nicolaas Schaper1 1Division of Endocrinology, Department of Inter- nal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands 2Research Unit for General Practice and Section of General Practice, Department of Public OBJECTIVE Health, University of Copenhagen, Copenhagen, Infection commonly complicates diabetic foot ulcers and is associated with a poor Denmark 3 outcome. In a cohort of individuals with an infected diabetic foot ulcer, we aimed Department of Endocrinology, University of Malmo,¨ Malmo,¨ Sweden to determine independent predictors of lower-extremity amputation and the 4International Diabetes Federation, Consultative predictive value for amputation of the International Working Group on the Di- Section and International Working Group on the abetic Foot (IWGDF) classification system and to develop a risk score for predicting Diabetic Foot, Heemstede, the Netherlands 5 amputation. Diabetic Department, Kings College Hospital, London, U.K. 6Copenhagen Wound Healing Centre, Bispebjerg RESEARCH DESIGN AND METHODS Hospital, Copenhagen, Denmark We prospectively studied 575 patients with an infected diabetic foot ulcer pre- 7Diabetes Centre, Institute for Clinical and Exper- senting to 1 of 14 diabetic foot clinics in 10 European countries. imental Medicine, Prague, Czech Republic 8Diabetes Centre, Tameside General Hospital, RESULTS Ashton-under-Lyne, U.K. 9Department of Endocrinology and Nutrition, Among these patients, 159 (28%) underwent an amputation. Independent risk Hospital de Sant Pau, Autonomous University factors for amputation were as follows: periwound edema, foul smell, (non)pu- of Barcelona, Barcelona, Spain rulent exudate, deep ulcer, positive probe-to-bone test, pretibial edema, fever, 10Sezione Dipartimentale Piede Diabetico, Dipar- and elevated C-reactive protein. Increasing IWGDF severity of infection also in- timento di Area Medica, Azienda Ospedaliero- Universitaria Pisana, Pisa, Italy dependently predicted amputation. We developed a risk score for any amputation 11Swedish Institute for Health Economics, Lund, and for amputations excluding the lesser toes (including the variables sex, pain on Sweden 12 palpation, periwound edema, ulcer size, ulcer depth, and peripheral arterial dis- Innere Abteilung, Mariannen Hospital, Werl, Germany ease) that predicted amputation better than the IWGDF system (area under the 13Mathias-Spital, Diabetic Department, Rheine, ROC curves 0.80, 0.78, and 0.67, respectively). Germany 14Policlinico Tor Vergata, Department of Internal PATHOPHYSIOLOGY/COMPLICATIONS CONCLUSIONS Medicine, Rome, Italy 15 For individuals with an infected diabetic foot ulcer, we identified independent Department of Endocrinology, University Med- fi ical Centre, Ljubljana, Slovenia predictors of amputation, validated the prognostic value of the IWGDF classi ca- 16Department of Endocrinology, H Familie tion system, and developed a new risk score for amputation that can be readily Ziekenhuis and Centre de Sante´ des Fagnes, used in daily clinical practice. Our risk score may have better prognostic accuracy Rumst and Chimay, Belgium 17 than the IWGDF system, the only currently available system, but our findings need Department of Surgery, Twenteborg Ziekenhuis, Almelo, the Netherlands to be validated in other cohorts. Corresponding author: Kristy Pickwell, k.pickwell@ mumc.nl. Infection is a frequent complication of diabetic foot ulcers, with up to 58% of ulcers Received 3 July 2014 and accepted 7 January being infected at initial presentation at a diabetic foot clinic, increasing to 82% in 2015. patients hospitalized for a diabetic foot ulcer (1). These diabetic foot infections This article contains Supplementary Data online (DFIs) are associated with poor clinical outcomes for the patient and high costs at http://care.diabetesjournals.org/lookup/ suppl/doi:10.2337/dc14-1598/-/DC1. for both the patient and the health care system (2). Patients with a DFI have © 2015 by the American Diabetes Association. a 50-fold increased risk of hospitalization and 150-fold increased risk of lower- Readers may use this article as long as the work extremity amputation compared with patients with diabetes and no foot infection is properly cited, the use is educational and not (3). Among patients with a DFI, ;5% will undergo a major amputation and 20–30% a for profit, and the work is not altered. care.diabetesjournals.org Pickwell and Associates 853 minor amputation, with the presence of score for amputation in individuals the hallux, excluding amputations of dig- peripheral arterial disease (PAD) greatly with a DFI from characteristics of the its 2–5. We performed analyses for both increasing amputation risk (4–6). Fur- foot (ulcer), the leg, and the patient of these outcomes, as amputations of thermore, lower-limb amputation is asso- that can readily be assessed by the clini- digits 2–5 could be considered function- ciated not only with significant morbidity cian at presentation to guide further ally less important for mobility and qual- and mortality but also with major psycho- management. ity of life and as part of treatment rather social and financial consequences (7–9). than a measure of poor outcome. As infection of a diabetic foot wound RESEARCH DESIGN AND METHODS Statistical Analyses heralds a poor outcome, early diagnosis Study Design Unadjusted associations between the and treatment are important. Unfortu- Between 1 September 2003 and 1 October 1-year amputation incidence and patient, nately, systemic signs of inflammation 2004, all patients with diabetes presenting leg, ulcer, and infection characteristics such as fever and leukocytosis are often with a new foot ulcer to any of 14 diabetic were tested with x2 tests (categorical absent even with a serious foot infection foot centers in 10 European countries characteristics) and t tests (continuous (10,11). As local signs and symptoms were included. Both in- and outpatients characteristics). The characteristics stud- of infection are also often diminished, were included. The design and rationale ied included sex, age, immobility, serum because of concomitant peripheral neu- of the multicenter, observational, prospec- creatinine, HbA1c, presence of PAD and ropathy and ischemia (12), diagnosing tive Eurodiale study have previously been polyneuropathy, ulcer size, depth, dura- and defining resolution of infection can described in detail (17). We excluded pa- tion and location, periwound redness, be difficult. Amputation, instead of res- tients treated in the participating centers (periwound) edema, pain, foul smell, olution of symptoms or signs of infec- for an ulcer of the ipsilateral foot during exudate/pus, increased local skin tem- tion, could therefore be a reliable the previous 12 months and those with a perature, lymphadenitis/lymphangitis, outcome measure. life expectancy of ,1 year. fever, and C-reactive protein (CRP) levels. The system developed by the Interna- Patients were followed monthly until The relation of the different character- tional Working Group on the Diabetic healing of the foot ulcer(s), major ampu- istics with amputation was analyzed in Foot (IWGDF) and the Infectious Dis- tation, or deathdup to a maximum of multivariable Cox proportional hazards eases Society of America (IDSA) provides 1 year. Healing was defined as complete regression models. In these analyses, a criteria for the diagnosis of infection epithelialization of the whole foot at hazard ratio (HR) .1 indicates a higher of ulcers and classifies it into three cate- two consecutive visits. All patients amputation rate for the corresponding gories: mild, moderate, or severe. The were treated according to protocols category of a certain characteristic com- system was validated in three relatively based on the International Consensus pared with a baseline category. For in- small cohorts of patients with a DFI on the Diabetic Foot (19). stance,anHRof2meansthatatany (13–15), and increasing severity of infec- Ulcer characteristics were described ac- time point during follow-up, the patients tion was associated with toe amputa- cording to the PEDIS system of the IWGDF, in the corresponding category are twice tions in one large cohort (16). While the which classifies foot ulcers according to as likely to undergo an amputation as the system seems valid in predicting ampu- five categories: perfusion, extent, depth, patients in the baseline category. tation, it does not take into account the infection, and sensation (19,20). The patient demographics and foot, ul- results of diagnostic tests such as probing Ankle-brachial index (ABI) ,0.9 was cer, and infection characteristics were used to bone and does not include more gen- considered to represent the presence to construct risk scores for any amputation eral patient characteristics that may of PAD. A deep ulcer was defined as a and for amputations excluding lesser toes have a major impact on the outcome lesion of the skin extending through the in patients with an infected ulcer. Firstly, a of a DFI. subcutis with visible
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