Risk Factors for Lower Limb Complications in Diabetic Patients

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<ul><li><p>Risk Factors for Lower Limb Complicationsin Diabetic PatientsMedhat El-Shazly, Moataz Abdel-Fattah, Nicola Scorpiglione, Massimo Massi Benedetti, FabioCapani, Fabrizio Carinci, Quirico Carta, Donatella Cavaliere, Eugenio M. De Feo, ClaudioTaboga, Gianni Tognoni, Antonio Nicolucci, on behalf of The Italian Study Group for theImplementation of the St. Vincent Declaration</p><p>ABSTRACT</p><p>Diabetic lower extremity complications may be predictor of lower extremity complicationscompared to NIDDM patients not being treatedinfluenced by a number of factors, including those</p><p>related to the interaction between patients and the with insulin. Cardio-cerebrovascular disease andpresence of diabetic neuropathy were associatedhealth-care system. Our objective is to identify risk</p><p>factors for the development of lower limb with a higher risk of being a case (OR 5 1.4,CI 1.21.8 and OR 5 3.0, CI 2.14.2, respectively).complications, by looking for classical clinical</p><p>variables and those related to quality of care. A Patients who needed help to reach the healthfacility before the onset of the complications andcase-control study was carried out between</p><p>December 1993 and June 1994 by interviewing 348 those who did not attend health facilities regularlywere more liable to develop complications (OR 5patients with lower-limb diabetic complications</p><p>and 1050 controls enrolled from 35 diabetes 1.5, CI 1.12.2 and OR 5 2.0, CI 1.33.0,respectively). Patients who had never receivedoutpatient clinics and 49 general practitioners</p><p>offices in Italy. Among sociodemographic educational intervention had a threefold risk ofbeing a case as compared to those who receivedcharacteristics associated with increased risk of</p><p>lower limb complications were male gender [odds health information regularly. The study identifiesfactors most likely to be related to adverseratio (OR) 5 2.5, confidence interval (CI) 1.63.9],</p><p>age between 50 and 70 years as opposed to outcome and permits to discriminate betweenavoidable and unavoidable factors. ( Journal ofyounger than 50 (OR 5 3.6, CI 2.16.3) and being</p><p>single as opposed to married (OR 5 1.4, CI 1.11.8). Diabetes and Its Complications 12;1:1017,1998.) 1998 Elsevier Science Inc.Among clinical variables, treatment with insulin</p><p>for IDDM and NIDDM patients was an important</p><p>INTRODUCTIONMedical Statistics and Clinical Epidemiology Department (M.E-S.,</p><p>M.A-F.), Medical Research Institute, Alexandria University, Alexan- Aconsiderable amount of disability in diabet-dria, Egypt; Department of Clinical Pharmacology and Epidemiol- ics is caused by the peculiar susceptibilityogy (N.S., F.C., D.C., G.T., A.N.), Istituto Di Ricerche Farracolo Giche of lower extremities to severe tissue dam-Mario Negri, Consorzio Mario Negri Sud, 66030 S. Maria ImbaroChieti; Institute of Internal Medicine (M.M.B.), Endocrine and Meta- age. The combination of chronic foot ulcer-bolic Science, University of Perugia, Perugia; Ospedale di Pescara ation, sepsis, and gangrene is the chief cause of pro-(F.C.), Centro di Diabetologia, Universita` di Chieti, Chieti; Ospedale longed hospitalization for diabetic patients and accountsMolinette, (Q.C.), Centro di Diabetologia, Torino; Ospedale Carda-relli (E.M.D.F.), XI Divisione di Medicina Interna e Diabetologia, ; for more than one-half of the nontraumatic amputa-and Ospedale Civile (C.T.), Servizio di Diabetologia, Udine, Italy tions performed in some developed countries.13 The</p><p>Reprint requests to be sent to: Dr. Antonio Nicolucci, Department age-adjusted risk for lower extremity amputation hasof Clinical Pharmacology and Epidemiology, Consorzio Mario NegriSud, 66030 S. Maria Imbaro, Chieti, Italy. been reported to be 15 times greater in diabetics than</p><p>Journal of Diabetes and Its Complications 12:1017 1998 Elsevier Science Inc. All rights reserved. 1056-8727/98/$19.00655 Avenue of the Americas, New York, NY 10010 PII S1056-8727(97)00001-9</p></li><li><p>J Diab Comp 1998; 12:1017 DIABETIC COMPLICATIONS OF LOWER LIMB 11</p><p>in nondiabetics.4 The major factors contributing to To obtain a substantial reduction of diabetic lowerextremity complications, it is thus necessary to identifydamage of the diabetic foot are neuropathy, arterial</p><p>atherosclerosis, and bacterial infection.5 Routine physi- the factors that are most relevant in defining the riskprofile of diabetic patients, particularly those factorscal examination may reveal clues leading to the diagno-</p><p>sis of neuropathy.6 that can be considered avoidable because they are re-lated to patients and doctors practices and attitudes.Generally, development of diabetic complications is</p><p>strictly related to metabolic control which is deter-METHODSmined by a variety of factors.7,8 Diabetic lower limb com-</p><p>plications, in turn, may be influenced by a number The study was carried out between December 1993of factors, including those related to the interaction and June 1994 in 17 of 20 Italian regions. It was a case-between patients and the health-care system. Problems control study15 in which patients were identified in 35related to accessibility of care, the patients satisfaction, diabetes outpatient clinics (DOCs) and 49 general prac-or co-ordination between the various health profes- titioners offices (GPs). All Italian citizens are healthsionals involved in the care of diabetic patients can insured and registered with a general practitioner. Onhave a major impact on the acceptability of medical average, 1545 diabetic patients are registered by eachrecommendations.911 Equally important in determin- GP. Clinical records for all registered diabetic patientsing good compliance and adequate self-care are factors were available both in DOCs and GPs, and tracing ofsuch as age, co-morbidity, socio-economic status, and patient follow-up visits was possible.social support.12,13 Patients with insulin-dependent diabetes mellitus</p><p>Starting from these premises, representatives of vari- (IDDM) or noninsulin-dependent diabetes mellitusous government health departments and patients organ- (NIDDM) with a duration of at least 5 years were in-izations met with diabetes experts under the aegis of cluded in the study as cases if they had foot ulcer,the Regional Office of the World Health Organization claudication, gangrene and/or ischemic rest pain lasting(WHO) and the International Diabetes Federation, in 15 days or more, by-pass or angioplasty for peripheralSaint Vincent, Italy, in October 1989. As a result of the vasculopathy, or if they had undergone amputationmeeting, 5-year targets were defined, directed primar- within the previous 12 months. In DOCs, all diabeticily to the reduction of major diabetic complications.14 patients eligible as cases were identified among sub-</p><p>jects seen during the study period. All eligible cases1 The Italian Study Group for the Implementation of the St. Vincent in the charge of GPs were enrolled. Patients were con-</p><p>Declaration included Co-ordinator: M. Massi Benedetti; Scientific Com- sidered eligible as controls if they had IDDM ormittee: F. Capani, Q. Carta, M.E. De Feo, C. Taboga, G. Tognoni; Co-ordinating Center: A. Nicolucci, D. Cavaliere, M. Abdel-Fattah, N. NIDDM with a duration of at least 5 years and if theyScorpiglione, M. Belfiglio, F. Carinci, M. El-Shazly, D. Labbrozzi, E. had never been affected by any of the aforementionedMari, G. Angeli, M. Olivieri. The Participating clinicians included complications of the lower limb. In general prac-Diabetes Clinics: S. Ponzano (Alessandria); P. Fumelli, P. Sorichetti(Ancona); G.M. Nardelli, A. DAlessandro (Bari); F. Farci (Cagliari); titioners offices, all eligible patients were enrolled asA. Aiello, M.R. Cristofaro (Campobasso); M. Padula, E. Simeone controls. After exclusion of patients who did not fulfil(Casoli); R. Biagioli, C. Santini (Cesena); V. Rotolo, P.M. Miniussi eligibility criteria, three controls for each case were(Cividale del Friuli); A. Berton, C. Ruffino (Finale Ligure); S. Pocciati(Foligno); C. Bordone (Genova); M. Tagliaferri, C. Vitale (Larino); enrolled. Because of the large number of patients inG. Brusco, E. Caruso (Lauria); A. Venezia (Matera); M.E. De Feo, P. the care of DOCs, a random sample was recruited asGuerriero, G. Corigliano, D. Vitale (Napoli); M. Trovati, C. Ponziani control from among eligible patients in such a way(Orbassano); E. Secchi (Ozieri); E. Savagnone (Palermo); C. Coscelli(Parma); M. Massi Benedetti, R. Norgiolini (Perugia); F. Capani, G. that the case/control ratio was the same as that GPs.La Penna (Pescara); D. Giorgi Pierfranceschi (Piacenza); R. Anichini This permitted to avoid any imbalance in the selection(Pistoia); G. Monesi, E. Cecchetto (Rovigo); S. De Cosmo, S. Bacci</p><p>of cases and controls from the two different sources(S. Giovanni Rotondo); G. Pipicelli, A. Mosca (Soverato); S. Albano,C. Spinelli (Taranto); Q. Carta, G. Petraroli, M. Porta, M. Tomalino that could have affected the risk estimate.(Torino); C. Taboga (Udine), G. Erle and L. Lora (Vicenza). GeneralPractitioners: M. Cappelletti (Alessandria); R. Giaretta (Altavilla Vi- Measurements. All patients enrolled in the study ascentina); E. Mossuto (Arqua` Polesine); A. Spina (Avellino); V. DAles- cases or controls received a 45 min interview by pre-sandro (Bari); F. Richeri (Caice Ligure); L. Pascali (Camerano); L.</p><p>viously trained physicians. Clinical data were obtainedPuddu (Cagliari); G. Ragazzi (Camisano); M. Rusco (Cardito); V.Biagini, I. Garavina (Cesena); F. Magini, C. Polidori (Citta` di by reviewing medical records. Questions focused uponCastello); S. Previato (Crespino); G.M. Masazza (Finale Ligure); L. exposures of interest including sociodemographic (age,Tomain (Fontecchio); A. Bragiotto (Frassinelle); M. Lioniello (Frat-</p><p>gender, marital status, education, and occupation),taminore); G. Di Menza (Fubine); E. Mazzoccato (Isola Vicentina);F. Gesualdi (Latronico); G. Capozza, F. Morelli, R. Tataranni clinical (type and duration of diabetes, co-morbidity(Matera); E. Saffi Guistini (Montale); E. Magliani, G. Sampaolo and presence of other diabetic complications), personal(Osimo); L. Galvano, L. Spicola (Palermo); E. Goracci, S. Sbrenna</p><p>(smoking and alcohol consumption), and health-care(Perugia); G. Meucci (Pistoia); S. Porru (Quartu S. Elena); A. Briganti,C.A. Belli (Recco); A. Benedetto, S. Burzacca (Rivalta di Torino); E. characteristics (accessibility, self-care, social support,De Bella, A. Di Carluccio, E. Fantini, P. Pietravalle, M. Turato (Roma); frequency of educational interventions received). ToS. Mella, F. Paparella (Rovigo); M. Bertone, M. Zoppi (Torino); G.Cabri (Vicenza); and E. Maragnano (Villadose). enhance uniformity and precision of measuring meth-</p></li><li><p>12 EL-SHAZLY ET AL. J Diab Comp 1998; 12:1017</p><p>ods, especially for data relying upon clinical judgment, effect of the variables, a multiple logistic regressionwas utilized for the final analysis, with backward selec-all the participating physicians were trained in data</p><p>collection, and questionnaire clarity and acceptability tion of the variables to be included in the final model.17</p><p>Both in univariate and multivariate analysis, the associ-were verified by interviewing a small number of pa-tients. The data collected referred to the patients clini- ation between exposures and outcome is thus ex-</p><p>pressed in terms of odds ratios (OR) together with theircal situation at the time of the interview. We also col-lected information on accessibility of health services 95% confidence intervals (95% CI).</p><p>All the explanatory variables included in the logisticand health habits relative to the previous 5 years, aperiod of time presumably antecedent to the develop- model were categorized into two or more levels, (RC 5</p><p>reference category): Age: younger than 50 years (RC),ment of lower limb complications, to test the effect ofthese variables as exposure factors. 5070 years, older than 70; Gender: females (RC), males;</p><p>Marital status: married (RC), single, divorced/wid-Patients were classified as having IDDM if their ageat diagnosis was under 30 years and insulin was used owed; Education: high (RC), intermediate, elementary,</p><p>illiterate; Occupation: professional/managerial (RC),continuously from the time of diagnosis. Patients wereconsidered as NIDDM if their age at diagnosis was technical/clerical, skilled workers/artisan, unskilled</p><p>worker, others; Type of diabetes: NIDDM (RC), IDDM,over 30 years with no evidence of ketonuria. Hyperten-sion was considered uncontrolled by treatment on the NIDDM-insulin treated; Duration of diabetes in years:</p><p>less than 10 years (RC), 1020 years, more than 20; Gly-basis of clinical judgment, and confirmed by the pres-ence of blood pressure values exceeding 160/90 mm cated hemoglobin level: within normal range (RC), ab-</p><p>normal; Co-morbidity: no (RC), one controlled, two con-Hg on the patients records. Similarly, patients wereclassified as having diabetic neuropathy on the basis of trolled, more than two or any uncontrolled; Cardio or</p><p>cerebrovascular disease: no (RC), yes; Diabetic neurop-the presence of clinical symptoms and signs. Glycatedhemoglobin levels referred to the last values in the athy: no (RC), yes; Eye complications: no (RC), yes;</p><p>Diabetic nephropathy: no (RC), yes; Accessibility to theprevious 12 months. Since normal ranges for glycatedhemoglobin varied in different centers, the percentage health-care facility: alone (RC), with help; Self-manage-change with respect to the upper normal value was ment of insulin therapy: yes (RC), no; Self-monitoringutilized (actual value/upper normal limit 3 100). Levels of glycemia: yes (RC), no; Regular follow-up visits: yesexceeding 30% of the upper normal value were consid- (RC), no; Regularity of diet: yes (RC), no; Frequencyered abnormal. Patients were considered as nephro- of educational interventions: regular (RC), occasional,patic if they underwent dialysis or had serum creati- never; Smoking: nonsmoker (RC), current, ex-smokernine level of 3 mg/dL or more. Co-morbidity included 5 years or less, ex-smoker more than 5 years; Alcoholconditions that had already been present previous to consumption: no (RC), 14 cups/day, more than 4the diagnosis of the complication (angina pectoris, hy- cups/day. Since we had no a priori hypothesis regard-pertension, renal disease, endocrine dysfunction, dis- ing possible interactions among the aforementionedlipidemia, and liver diseases). In the classification ac- variables, and to avoid overfitting of the logistic model,cording to employment status, considered as a proxy no interaction term was included in the analysis.for socio-economic status, husbands employment was</p><p>RESULTSconsidered for housewives, whereas the last employ-ment status was considered for retired patients. Infor- A total of 348 diabetic cases with major complicationsmation on the compliance with visit scheduling and with of the lower extremities and 1050 diabetic patients withdietary recommendations was based on the physicians no complications of the lower extremities were re-judgment. cruited. The soci...</p></li></ul>