RESUMEN
AIMS/HYPOTHESIS: We investigated the significance of microangiopathy in the development of foot ulcer, which is still disputed. METHODS: We assessed microangiopathy by histological analysis of the capillary ultrastructure using transmission electron microscopy and capillary density and arteriolar morphology in paraffin-embedded sections from the skin of type 2 diabetic patients: 30 neuroischaemic patients (Isc) revascularised with peripheral angioplasty and 30 neuropathic patients (Neu) with foot ulcer, compared with ten non-diabetic volunteers. RESULTS: In the diabetic patients, capillaries in the dermal papillary layer were fewer (-22.2%, 159 ± 43 vs 205 ± 52 mm(2) in non-diabetic volunteers, p < 0.01). They also showed detrimental remodelling, with a 2.2-fold increase in capillary basement membrane thickness (3.44 ± 1.19 vs 1.53 ± 0.34 µm in non-diabetic volunteers, p < 0.001) and a 57.7% decrease in lumen area (14.6 ± 11.1 vs 34.7 ± 27.5 µm(2), p < 0.001). No differences were observed between the diabetic Isc or Neu patients. Isc were more prone to develop arteriolar occlusion than Neu (16.8 ± 6.9% vs 6.7 ± 3.7%, respectively, p < 0.001). No patient had been amputated at 30 days and healing time was significantly longer in Isc (180 ± 120 vs 64 ± 50 days in Neu, p < 0.001). CONCLUSIONS/INTERPRETATION: Capillary microangiopathy is present in equal measure in neuroischaemic and neuropathic diabetic foot skin. The predominance of arteriolar occlusions with neuroischaemia indicated the existence of an additional 'small vessel disease' that did not affect an effective revascularisation and did not worsen the prognosis of major amputations but slowed the healing process of the neuroischaemic foot ulcer. TRIAL REGISTRATION: ClinicalTrials.gov NCT02610036.
Asunto(s)
Diabetes Mellitus Tipo 2/patología , Angiopatías Diabéticas/patología , Úlcera del Pie/patología , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Microscopía Electrónica de Transmisión , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
The purpose of the present retrospective study was to evaluate the outcomes (ie, ulcer recurrence, major amputation, death) in diabetic patients undergoing Chopart amputation because of deep infection or gangrene extending to the midfoot. From 2009 to 2011, 83 patients, aged 71.4 ± 9.3 years, underwent a midtarsal amputation and were followed up until December 31, 2012 (mean follow-up 2.8 ± 0.8 years). Of the 83 patients, 26 were female, 61 required insulin, 47 had renal insufficiency, 19 underwent hemodialysis, 65 had hypertension, 34 had a history of cardiac disease, and 4 had a history of stroke. Chopart amputation was performed in 38 patients (45.8%) with gangrene, 31 (37.4%) with abscess, and 14 (16.9%) with osteomyelitis. Urgent surgery was performed in 56 patients (67.5%). Effective revascularization was performed in 64 patients (77.1%) patients. Of the 83 patients, 47 had healed at a mean period of 164.7 (range 11 to 698) days. Ulcer recurrence developed in 15 patients (31.9%). A major amputation was necessary in 23 patients (27.7%), with an annual incidence of 13.0%. None of the included variables on logistic regression analysis was significantly associated with proximal amputation. Of the 83 patients, 38 (45.8%) died, with an annual incidence of 25.8%. On logistic regression analysis, age (odds ratio [OR] 1.11, 95% confidence interval [CI] 1.01 to 1.16), history of stroke (OR 9.94, 95% CI 3.16 to 31.24), and urgent surgery (OR 2.60, 95% CI 1.14 to 5.93) were associated with mortality. Chopart amputation represents the last chance to avoid major amputation for diabetic patients with serious foot complications. Our success rate was great enough to consider Chopart amputation a viable option for limb salvage in this high-risk population.
Asunto(s)
Amputación Quirúrgica , Pie Diabético/cirugía , Absceso/etiología , Absceso/cirugía , Anciano , Anciano de 80 o más Años , Amputación Quirúrgica/efectos adversos , Pie Diabético/complicaciones , Pie Diabético/fisiopatología , Femenino , Gangrena/etiología , Gangrena/cirugía , Humanos , Recuperación del Miembro , Masculino , Persona de Mediana Edad , Osteomielitis/etiología , Osteomielitis/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Cicatrización de HeridasRESUMEN
RATIONALE: Circulating proangiogenic cells (PACs) support postischemic neovascularization. Cardiovascular disease and diabetes mellitus impair PAC regenerative capacities via molecular mechanisms that are not fully known. We hypothesize a role for microRNAs (miRs). Circulating miRs are currently investigated as potential diagnostic and prognostic biomarkers. OBJECTIVE: The objectives were the following: (1) to profile miR expression in PACs from critical limb ischemia (CLI) patients; (2) to demonstrate that miR-15a and miR-16 regulate PAC functions; and (3) to characterize circulating miR-15a and miR-16 and to investigate their potential biomarker value. METHODS AND RESULTS: Twenty-eight miRs potentially able to modulate angiogenesis were measured in PACs from CLI patients with and without diabetes mellitus and controls. miR-15a and miR-16 were further analyzed. CLI-PACs expressed higher level of mature miR-15a and miR-16 and of the primary transcript pri-miR-15a/16-1. miR-15a/16 overexpression impaired healthy PAC survival and migration. Conversely, miR-15a/16 inhibition improved CLI-PAC-defective migration. Vascular endothelial growth factor-A and AKT-3 were validated as direct targets of the 2 miRs, and their protein levels were reduced in miR-15a/16-overexpressing healthy PACs and in CLI-PACs. Transplantation of healthy PACs ex vivo-engineered with anti-miR-15a/16 improved postischemic blood flow recovery and muscular arteriole density in immunodeficient mice. miR-15a and miR-16 were present in human blood, including conjugated to argonaute-2 and in exosomes. Both miRs were increased in the serum of CLI patients and positively correlated with amputation after restenosis at 12 months postrevascularization of CLI type 2 diabetes mellitus patients. Serum miR-15a additionally correlated with restenosis at follow-up. CONCLUSIONS: Ex vivo miR-15a/16 inhibition enhances PAC therapeutic potential, and circulating miR-15a and miR-16 deserves further investigation as a prognostic biomarker in CLI patients undergoing revascularization.
Asunto(s)
Complicaciones de la Diabetes/sangre , Miembro Posterior/irrigación sanguínea , Isquemia/sangre , MicroARNs/efectos adversos , Neovascularización Patológica/sangre , Animales , Movimiento Celular/genética , Supervivencia Celular/genética , Trasplante de Células/métodos , Células Cultivadas , Complicaciones de la Diabetes/genética , Complicaciones de la Diabetes/patología , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/genética , Diabetes Mellitus Tipo 2/patología , Células HEK293 , Miembro Posterior/patología , Humanos , Isquemia/genética , Ratones , Ratones Desnudos , MicroARNs/biosíntesis , Neovascularización Patológica/genéticaRESUMEN
BACKGROUND: To compare demographic and clinical characteristics, revascularization, major amputation, and mortality among patients admitted to a diabetic foot center because of critical limb ischemia (CLI) during 1999-2003 (cohort 1) and 2009 (cohort 2). METHODS: During 1999-2003, 564 diabetic patients with CLI (cohort 1) were admitted to our center, and 344 patients (360 affected limbs) were admitted during 2009 (cohort 2). Data on demographic and clinical characteristics, revascularization by peripheral angioplasty (PTA) or bypass graft (BPG), major amputation, and mortality were recorded. RESULTS: Patients belonging to cohort 2 were older than patients of cohort 1 (P = 0.001). In cohort 2, there were more subjects requiring insulin (P = 0.008) and duration of diabetes was longer (P = 0.001); moreover, there were more patients requiring dialysis (P = 0.001), patients with history of stroke (P = 0.004), or foot ulcer (P = 0.001). No significant difference between the 2 groups was found concerning gender, metabolic control, hypertension, lipid values, neuropathy, and retinopathy. Occlusion was more frequent than stenosis in the posterior tibial (P < 0.001) and peroneal (P = 0.016) arteries. However, the revascularization rate did not differ (P = 0.318) between the 2 groups. Restenosis after PTA was not significantly different (P = 0.627), whereas BPG failure was significantly more frequent (P = 0.010) in cohort 2 (2009). Major amputation (P = 0.222) and mortality rate (P = 0.727) did not differ between the 2 groups. CONCLUSIONS: The severity of either foot lesions or patients comorbidities should be concomitantly assessed and taken into proper consideration when evaluating changes in the amputation rate among different studies or in different temporal settings.
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Amputación Quirúrgica , Pie Diabético/mortalidad , Pie Diabético/cirugía , Isquemia/mortalidad , Isquemia/cirugía , Pierna/irrigación sanguínea , Anciano , Angioplastia , Implantación de Prótesis Vascular , Estudios de Cohortes , Comorbilidad , Femenino , Humanos , Recuperación del Miembro , Masculino , Factores de Riesgo , Índice de Severidad de la Enfermedad , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
OBJECTIVE: The p75 neurotrophin receptor (p75(NTR)) contributes to diabetes mellitus-induced defective postischemic neovascularization. The interleukin-33 receptor ST2 is expressed as transmembrane (ST2L) and soluble (sST2) isoforms. Here, we studied the following: (1) the impact of p75(NTR) in the healing of ischemic and diabetic calf wounds; (2) the link between p75(NTR) and ST2; and (3) circulating sST2 levels in critical limb ischemia (CLI) patients. METHODS AND RESULTS: Diabetes mellitus was induced in p75(NTR) knockout (p75KO) mice and wild-type (WT) littermates by streptozotocin. Diabetic and nondiabetic p75KO and WT mice received left limb ischemia induction and a full-thickness wound on the ipsilateral calf. Diabetes mellitus impaired wound closure and angiogenesis and increased ST2 expression in WT, but not in p75KO wounds. In cultured endothelial cells, p75(NTR) promoted ST2 (both isoforms) expression through p38(MAPK)/activating transcription factor 2 pathway activation. Next, sST2 was measured in the serum of patients with CLI undergoing either revascularization or limb amputation and in the 2 nondiabetic groups (with CLI or nonischemic individuals). Serum sST2 increased in diabetic patients with CLI and was directly associated with higher mortality at 1 year from revascularization. CONCLUSIONS: p75(NTR) inhibits the healing of ischemic lower limb wounds in diabetes mellitus and promotes ST2 expression. Circulating sST2 predicts mortality in diabetic CLI patients.
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Diabetes Mellitus Experimental/fisiopatología , Diabetes Mellitus/mortalidad , Isquemia/fisiopatología , Extremidad Inferior/irrigación sanguínea , Proteínas del Tejido Nervioso/fisiología , Receptores de Superficie Celular/metabolismo , Receptores de Interleucina/metabolismo , Receptores de Factor de Crecimiento Nervioso/fisiología , Factor de Transcripción Activador 2/metabolismo , Anciano , Anciano de 80 o más Años , Animales , Biomarcadores/metabolismo , Células Cultivadas , Complicaciones de la Diabetes/complicaciones , Diabetes Mellitus/metabolismo , Diabetes Mellitus/fisiopatología , Diabetes Mellitus Experimental/inducido químicamente , Diabetes Mellitus Experimental/metabolismo , Modelos Animales de Enfermedad , Endotelio Vascular/efectos de los fármacos , Endotelio Vascular/metabolismo , Endotelio Vascular/patología , Femenino , Humanos , Proteína 1 Similar al Receptor de Interleucina-1 , Isquemia/etiología , Masculino , Ratones , Ratones Noqueados , Persona de Mediana Edad , Proteínas del Tejido Nervioso/farmacología , Valor Predictivo de las Pruebas , Receptores de Factor de Crecimiento Nervioso/deficiencia , Receptores de Factor de Crecimiento Nervioso/genética , Estreptozocina/efectos adversos , Cicatrización de Heridas/fisiología , Proteínas Quinasas p38 Activadas por Mitógenos/metabolismoRESUMEN
BACKGROUND: To evaluate the prevalence of osteomyelitis in different areas of the foot and the possible correlation between localization and outcome of major amputation. METHODS: From January 2008 to December 2010, a total of 350 diabetic patients were admitted to our diabetic foot unit for the surgical treatment of osteomyelitis. Osteomyelitis was diagnosed when both the probe-to-bone maneuver and plain radiography were positive. In all of these patients, osteomyelitis was confirmed by histological examination. RESULTS: Osteomyelitis was localized to the forefoot in 300 (85.7%) patients, to the midfoot in 27 (7.7%) patients, and to the hindfoot in the remaining 23 (6.75) patients. On average, foot lesions had developed 6.6 ± 5.6 months before admission to our unit. Transtibial amputation was performed in 1 (0.33%) patient with forefoot osteomyelitis, in 5 (18.5%) patients with midfoot osteomyelitis, and in 12 (52.2%) patients with osteomyelitis of the heel (χ(2) = 128.4, P < .001). Multivariate analysis showed the independent role that osteomyelitis in the heel region had in major amputation outcome (odds ratio 15.3; P < .001; confidence interval, 17.4-5336.0), dialysis treatment (odds ratio 6.3; P = .012; confidence interval, 2.5-1667.2), and leukocyte count greater than 10(3) mm(3) (odds ratio 2.25; P = .036; confidence interval, 1.1-76.6). CONCLUSIONS: We found a higher rate of transtibial amputation when osteomyelitis involved the heel instead of the midfoot or forefoot in diabetic patients. LEVEL OF EVIDENCE: Level III, retrospective comparative series.
Asunto(s)
Amputación Quirúrgica/estadística & datos numéricos , Pie Diabético/microbiología , Pie Diabético/cirugía , Osteomielitis/cirugía , Anciano , Pie Diabético/complicaciones , Femenino , Antepié Humano/microbiología , Antepié Humano/cirugía , Talón/microbiología , Talón/cirugía , Humanos , Recuento de Leucocitos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Osteomielitis/etiología , Osteomielitis/microbiología , Diálisis Renal , Tibia/cirugíaRESUMEN
From January 2008 to December 2010, 452 patients with diabetes were admitted to our diabetic foot unit because of deep soft tissue abscess (group A: n = 210) or chronic osteomyelitis (group B: n = 242). Patients from group A underwent emergency debridement in the operating room. Patients from group B underwent elective surgery. Twenty-six (5.8%) major amputations were performed: of these, 18 (8.57%) were performed in patients from group A and 8 (3.31%) were performed in patients from group B (p = .024). Multivariate analysis showed the independent role on amputation outcome of the abscess (odds ratio, 2.64; p = .029; confidence interval [CI] 1.11 to 6.28), dialysis treatment (odds ratio, 3.17; p = .039, CI 1.06-9.51), and C-reactive protein > 0.5 mg/dL (odds ratio, 3.75; p = .022, CI 1.21-11.64). In group A, 43 (22.6%) patients healed only with drainage, and 147 (70.0%) minor amputations were performed: 53 (36.1%) at the level of the forefoot and 94 (63.9%) at the level of the midfoot. In group B, 234 (96.7%) minor amputations were performed, 208 (88.9%) at the forefoot and 26 (11.1%) at the midfoot level (p < .001). Fourteen postoperative complications occurred in patients from group A and 2 in patients from group B (p < .001). In group A, 3 patients died during hospitalization, 1 from septic shock and 2 from sudden death. None of the group B patients died. This study demonstrates that the severity of a foot soft tissue abscess is not comparable with that of a chronic osteomyelitis not only because of a higher rate of major amputation, but also because of a much more proximal level of minor amputation.
Asunto(s)
Absceso/terapia , Pie Diabético/complicaciones , Osteomielitis/terapia , Absceso/etiología , Anciano , Amputación Quirúrgica/estadística & datos numéricos , Proteína C-Reactiva/análisis , Desbridamiento , Drenaje , Femenino , Pie/cirugía , Mortalidad Hospitalaria , Humanos , Masculino , Análisis Multivariante , Osteomielitis/etiología , Complicaciones Posoperatorias , Pronóstico , Diálisis Renal , Estudios RetrospectivosRESUMEN
From January 2007 to December 2009, 207 diabetic patients were consecutively admitted to our foot center because of osteomyelitis of a phalanx or metatarsal head. The removal of infected bone was performed by internal bone resection in 110 patients (group A) and amputation in 97 patients (46.9%; group B). Dehiscence occurred in 15 patients (13.6%) patients in group A and 10 patients (10.3%) in group B (p = 0.464). A total of 206 patients (99.5%) were followed up from January 1, 2007 to December 31, 2011. Ulcer relapse occurred in 12 patients (12.4%) in group A and 18 patients (16.4%) in group B (p = .437). A contralateral ulcer occurred in 10 group A patients (10.3%) and 14 group B patients (12.7%; p = .667). The results of the present study have demonstrated that bone resection with preservation of the soft tissue envelope is feasible in approximately one half of diabetic patients with forefoot osteomyelitis and does not result in any risk of major dehiscence or ulcer recurrence compared with ray or toe amputation.
Asunto(s)
Amputación Quirúrgica , Pie Diabético/cirugía , Huesos Metatarsianos/cirugía , Osteomielitis/cirugía , Falanges de los Dedos del Pie/cirugía , Anciano , Amputación Quirúrgica/efectos adversos , Estudios de Factibilidad , Femenino , Úlcera del Pie/etiología , Antepié Humano , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Dehiscencia de la Herida Operatoria/etiología , Resultado del TratamientoRESUMEN
PURPOSE: To report a retrospective evaluation of the 6-F Angio-Seal closure device in antegrade and retrograde common femoral artery (CFA) punctures during endovascular procedures in diabetic patients with critical limb ischemia (CLI). METHODS: From January 2005 to March 2009, 2374 diabetic CLI patients underwent interventional procedures in the lower limbs at a single center under systemic anticoagulation (heparin 70 U/kg). In this population, 2016 patients (1184 men; mean age 69.6+/-9.1 years) had 2372 CFA punctures treated with either manual compression [205 punctures in 161 (8.0%) patients] or Angio-Seal deployment (2167 punctures in 1855 patients) and were eligible for this analysis. In the study cohort, there were 1889 antegrade CFA punctures closed with the device in 1626 (87.6%) patients compared to 278 retrograde punctures sealed in 229 (12.4%) patients. The complications from the antegrade CFA punctures were compared to those from retrograde closure and manual compression. RESULTS: The success rate for achieving hemostasis after antegrade and retrograde Angio-Seal placement was 97.9% and 97.8%, respectively. Major complications following antegrade Angio-Seal deployment, retrograde Angio-Seal deployment, and manual compression occurred in 20/1889 (1.1%), 5/278 (1.8%), and 4/205 (2.0%) cases, respectively. All complications developed within 24 hours of the procedure. No further complications were recorded in the 18-month follow-up (range 1-36). The overall complication rates after antegrade puncture closure, retrograde puncture closure, and manual compression at 30 days was 2.5%, 4.0%, and 4.9%, respectively (p = NS). CONCLUSION: This retrospective study shows that the 6-F Angio-Seal is a valuable and safe vascular closure device for percutaneous transfemoral antegrade access in diabetic patients undergoing interventional procedures for CLI.
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Cateterismo Periférico/efectos adversos , Angiopatías Diabéticas/terapia , Arteria Femoral , Hemorragia/prevención & control , Técnicas Hemostáticas/instrumentación , Isquemia/terapia , Extremidad Inferior/irrigación sanguínea , Anciano , Anticoagulantes/uso terapéutico , Distribución de Chi-Cuadrado , Enfermedad Crítica , Angiopatías Diabéticas/diagnóstico por imagen , Diseño de Equipo , Femenino , Hemorragia/etiología , Técnicas Hemostáticas/efectos adversos , Humanos , Isquemia/diagnóstico por imagen , Italia , Masculino , Persona de Mediana Edad , Presión , Punciones , Radiografía , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
In this study, we evaluated the utility of a dermal substitute for preserving maximal foot length after urgent surgical debridement. Patients referred to our Diabetic Foot Center with foot lesions were assessed for sensory-motor neuropathy, infection and critical limb ischaemia. The presence of acute foot infection indicated the need for immediate surgical debridement. The degree of amputation, if necessary, was based on the amount of apparently non infected vital tissue. When vital tendon/bone tissue remained exposed, the lesion was covered with a dermal substitute. From January to December 2008, 393 patients underwent surgical treatment for diabetic foot syndrome; 30 patients underwent immediate surgical debridement resulting in exposed tendon and/or bone tissues. An average of 4.4 +/- 2.1 days following surgical debridement, all 30 patients underwent dermal regeneration template grafting to cover-exposed healthy tendon and bone tissues, instead of achieving primary wound closure with a proximal amputation. After 21 days, a skin graft was performed. Complete wound healing occurred in 26 patients (86.7%). In these patients, the amputation level was significantly more distal (P < 0.003) with respect to that potentially required for immediate wound closure. The average healing time was 74.1 +/- 28.9 days. Four patients underwent a more proximal amputation. No patients underwent major amputation. The use of the dermal substitute for treating exposed tendon and bone tissues allowed timely wound healing and preserved maximal foot length. Continued follow-up will allow assessment of long-term relapse and complication rates. Such treatment could constitute part of the comprehensive management of diabetic wounds.
Asunto(s)
Infecciones Bacterianas/cirugía , Sulfatos de Condroitina/uso terapéutico , Colágeno/uso terapéutico , Desbridamiento/métodos , Pie Diabético/complicaciones , Infección de Heridas/cirugía , Enfermedad Aguda , Anciano , Amputación Quirúrgica/efectos adversos , Amputación Quirúrgica/métodos , Infecciones Bacterianas/clasificación , Infecciones Bacterianas/diagnóstico , Infecciones Bacterianas/etiología , Distribución de Chi-Cuadrado , Desbridamiento/efectos adversos , Urgencias Médicas , Femenino , Humanos , Masculino , Estudios Retrospectivos , Zapatos , Trasplante de Piel/métodos , Factores de Tiempo , Resultado del Tratamiento , Cicatrización de Heridas , Infección de Heridas/clasificación , Infección de Heridas/diagnóstico , Infección de Heridas/etiologíaRESUMEN
We studied the incidence of critical limb ischemia (CLI) and amputation outcome of the contralateral limb in 533 diabetic patients hospitalized in our diabetic foot centre because of CLI from 1999 to 2003 and followed-up until 2005. The cumulative incidence rate during the 6-year period reached 49.8% (CI confidence interval=40.6-59.6). All patients underwent arteriography and in 181 (98.4%) the revascularization was performed without different feasibility (p=0.077) compared to that (95.3%) in the initial patients. The severity of lesion evaluated with Wagner grade was lower (chi(2)=33.5, p<0.001) and also the frequency of midfoot and above-the-ankle amputations was lower (p<0.001 and p=0.022, respectively) in contralateral patients. There was no evidence from the logistic analysis to support the association between any of the investigated variables and incidence of CLI in the contralateral limb. Over a 6-year period, almost 50% of the diabetic patients with unilateral CLI developed a CLI in the contralateral limb: however, both severity of foot lesion and amputation level was significantly lower. This fact can be due to prompt therapeutic interventions, made possible thanks to an increased patient awareness acquired by training during the treatment of the unilateral limb.
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Amputación Quirúrgica , Complicaciones de la Diabetes/patología , Diabetes Mellitus/epidemiología , Extremidades/patología , Isquemia/cirugía , Anciano , Anciano de 80 o más Años , Complicaciones de la Diabetes/cirugía , Extremidades/cirugía , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Evaluated the efficacy of reducing the risk of cardiac events by a preclinical diagnosis of CAD in subjects with type 2 diabetes mellitus with 2 or more cardiovascular risk factors. METHODS: One hundred forty-one subjects with type 2 diabetes mellitus without known cardiac disease and asymptomatic, aged >45 to <76 years, were randomized into the screening arm for CAD (71 patients) or to the control arm (70 patients). The screening consisted in performing an exercise electrocardiogram test and dipyridamole stress echocardiography; if 1 test was abnormal, coronary angiography is done. Screening was positive in 15 subjects (21.4%). At coronary angiography, which was performed in 14 of 15 patients, stenoses > or =50% of vessel diameter were present in 9 patients, of these 4 underwent coronary artery bypass grafting and 4 underwent percutaneous transluminal coronary angioplasty. Stenoses <50% of vessel diameter were present in 5 patients. RESULTS: Mean follow-up was 53.5 months (range, 42-54 months). During this period, 1 major (myocardial infarction) and 3 minor events (angina) occurred in the screening arm. Eleven major and 4 minor events occurred in the control arm. In the screened arm, the proportion of all events was significantly less (P = .018) (RR .226, 95% CI 0.707-0.719, P = .012); the proportion of major to minor events was significantly less (P = .006) (RR .07, 95% CI 0.0087-0.565, P = .013). CONCLUSIONS: The preclinical diagnosis of CAD is effective in reducing the risk of cardiac events, especially major events, in subjects with type 2 diabetes mellitus at high cardiovascular risk.
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Enfermedad Coronaria/diagnóstico , Diabetes Mellitus Tipo 2/complicaciones , Anciano , Análisis de Varianza , Angiografía Coronaria , Enfermedad Coronaria/etiología , Enfermedad Coronaria/mortalidad , Enfermedad Coronaria/prevención & control , Ecocardiografía de Estrés , Prueba de Esfuerzo , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Infarto del Miocardio/prevención & control , Proyectos Piloto , Factores de RiesgoRESUMEN
OBJECTIVE: To evaluate the reulceration and reamputation rates in a cohort of diabetic patients following first ray amputation. RESEARCH DESIGN AND METHODS: We evaluated a cohort of 89 diabetic patients, 63 men and 26 women, who underwent first ray amputation in the period from January 2000 to December 2001. The first ray lesions were Wagner grade 2 in 3 patients, Wagner grade 3 in 47 patients, and Wagner grade 4 in 39 patients. Following surgical wound healing, all patients wore special footwear with rocker bottom soles and custom molded insoles and were put on an intensive secondary prevention program. RESULTS: The mean follow-up duration was 16.35 +/- 6.76 months (range 7-28). Fifteen patients developed new ulcerations, with 11 lesions occurring ipsilaterally and 4 contralaterally to the first ray amputation. In seven patients, the new lesion was treated and healed with dressing. Eight patients underwent a new surgical procedure: panmetatarsal head resection in four patients, toe amputation in two patients, a transmetatarsal amputation in one patient, and Lisfranc's amputation in one patient. CONCLUSIONS: In the population studied, the first ray amputation presented a lower reulceration and reamputation rate with respect to that reported in the literature. This finding should therefore be attributed to the follow-up program, which uses shoes with a rocker bottom sole and custom molded insoles and intensive ambulatory check-ups.
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Amputación Quirúrgica/métodos , Pie Diabético/cirugía , Huesos Metatarsianos/cirugía , Anciano , Pie Diabético/prevención & control , Retinopatía Diabética/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/patología , Recurrencia , Zapatos , Cicatrización de HeridasRESUMEN
OBJECTIVE: To evaluate the clinical efficacy and safety of HYAFF 11-based autologous dermal and epidermal grafts in the management of diabetic foot ulcers. RESEARCH DESIGN AND METHODS: A total of 79 patients with diabetic dorsal (n = 37) or plantar (n = 42) ulcers were randomized to either the control group with nonadherent paraffin gauze (n = 36) or the treatment group with autologous tissue-engineered grafts (n = 43). Weekly assessment, aggressive debridement, wound infection control, and adequate pressure relief (fiberglass off-loading cast for plantar ulcers) were provided in both groups. Complete wound healing was assessed within 11 weeks. Safety was monitored by adverse events. RESULTS: Complete ulcer healing was achieved in 65.3% of the treatment group and 49.6% of the control group (P = 0.191). The Kaplan-Meier mean time to closure was 57 and 77 days, respectively, for the treatment versus control groups. Plantar foot ulcer healing was 55% and 50% in the treatment and control groups, respectively. Dorsal foot ulcer healing was significantly different, with 67% in the treatment group and 31% in the control group (P = 0.049). The mean healing time in the dorsal treatment group was 63 days, and the odds ratio for dorsal ulcer healing compared with the control group was 4.44 (P = 0.037). Adverse events were equally distributed between the two groups, and none were related to the treatments. CONCLUSIONS: The autologous tissue-engineered treatment exhibited improved healing in dorsal ulcers when compared with the current standard dressing. For plantar ulcers, the off-loading cast was presumably paramount and masked or nullified the effects of the autologous wound treatment. This treatment, however, may be useful in patients for whom the total off-loading cast is not recommended and only a less effective off-loading device can be applied.
Asunto(s)
Dermis/trasplante , Pie Diabético/tratamiento farmacológico , Pie Diabético/cirugía , Epidermis/trasplante , Ácido Hialurónico/análogos & derivados , Ácido Hialurónico/administración & dosificación , Trasplante de Piel , Vendajes/efectos adversos , Terapia Combinada , Humanos , Ácido Hialurónico/efectos adversos , Infecciones , Parafina , Estudios Prospectivos , Trasplante Autólogo , Resultado del Tratamiento , Cicatrización de HeridasRESUMEN
OBJECTIVE: To report the cardiac events in type 2 diabetic outpatients screened for unknown asymptomatic coronary heart disease (CHD) and followed for 5 years. RESEARCH DESIGN AND METHODS: During 1993, 925 subjects aged 40-65 years underwent an exercise treadmill test (ETT). If it was abnormal, the subjects then underwent an exercise scintigraphy. Of the 925 subjects, 735 were followed for 5 years and cardiac events were recorded. RESULTS: At the entry of the study, 638 of the 735 followed subjects had normal ETT, 45 had abnormal ETT with normal scintigraphy, and 52 had abnormal ETT and abnormal scintigraphy. The 52 subjects with abnormal scintigraphy and ETT underwent a cardiological and diabetological follow-up; the subjects with just abnormal ETT had a diabetological follow-up only. During the follow-ups, 42 cardiac events occurred: 1 fatal myocardial infarction (MI), 20 nonfatal MIs, and 10 cases of angina in the 638 subjects with normal ETT; 1 fatal MI in the 45 subjects with normal scintigraphy; and 1 fatal MI and 9 cases of angina in the 52 subjects with abnormal scintigraphy. In these 52 subjects all cardiac events were significantly more frequent (chi(2) = 21.40, P < 0.0001) but the ratio of major (cardiac death and MI) to minor (angina) cardiac events was significantly lower (P = 0.002). Scintigraphy abnormality (hazard ratio 5.47; P < 0.001; 95% CI 2.43-12.29), diabetes duration (1.06; P = 0.021; 1.008-1.106), and diabetic retinopathy (2.371; P = 0.036; 1.059-5.307) were independent predictors of cardiac events on multivariate analysis. CONCLUSIONS: The low ratio of major to minor cardiac events in the positive scintigraphy group may suggest, although it does not prove, that the screening program followed by appropriate management was effective for the reduction of risk of major cardiac events.
Asunto(s)
Enfermedad Coronaria/diagnóstico , Diabetes Mellitus Tipo 2/fisiopatología , Angiopatías Diabéticas/epidemiología , Angiopatías Diabéticas/fisiopatología , Distribución por Edad , Anciano , Presión Sanguínea , Índice de Masa Corporal , Péptido C/sangre , Prueba de Esfuerzo , Estudios de Seguimiento , Humanos , Italia , Lípidos/sangre , Tamizaje Masivo , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , FumarRESUMEN
Cardiac rehabilitation is accepted as an important component in the management of heart disease. Diabetes Mellitus is a chronic disease frequently associated to ischemic heart disease and both disease require continuing medical care, aggressive treatment of other risk factors, educational programs for self management of disease to prevent acute complication. The scientific community should offer standard of care for management of diabetic patients with coronary artery disease, and should design new strategies to promote prevention in this high risk patients. The need to define characteristics and peculiar problems of diabetics patients with ischemic heart disease encouraged the Board of the Italian Group of Cardiac Rehabilitation and Prevention (GICR) to set up a working group composed of cardiologists and diabetologists chosen on the basis of their proven specific experience. The document is subdivided in six parts. In the first section is described the cardiovascular risks in patients with diabetes and the importance of post-prandial hyperglycemia and glycemic variability. We analyse also the difference in prevalence of ischemic heart disease in Italian diabetic patients compared with other countries. In the second section we described clinical presentation of ischemic heart disease in diabetic patients such as acute myocardial infarction and unstable angina, and the revascularization procedures (balloon angioplasty and coronary bypass surgery). We analysed the differences between the procedures and the evidence-based results. In patients with myocardial infarction we analysed the evidence-based therapy and specific advantages of aspirin, beta-blockers and ace-inhibitor in diabetic patients. In this section we also posed particular attention to the clinical course of patients who underwent bypass grafting and to the impact of diabetes on short and long-term results and on main intervention-related complications including deep infections, mediastinitis, neurological problems, renal failure. In the third section we evaluated the factors responsible of atherosclerosis progression and their treatment, and we underlined that cardiac rehabilitation is less effective for patients with diabetes mellitus. Suggestions proposed in this paper about risk factors are in line with the recommendations of standards guidelines of American Diabetics Association. In patients with concomitant diabetes and ischemic heart disease we suggest blood pressure <130/80, LDL-cholesterol <100 mg/dl, triglycerides <150 mg/dl and daily physical activity. In the fourth section we analysed therapeutic regimens and management of diabetes. We posed particular attention on insulin therapy in acute phase of myocardial infarction and in recent coronary bypass grafting, and chronic use of oral antidiabetic drugs or insulin. In the fifth section we provided some recommendations on the organization of educational programs and physical activity in these patients. In the last section we provided some information on diagnosis of coronary artery disease in diabetes, aim of screening and in which patients is need to perform diagnostic tests. We described the available diagnostic tests with the differences in each method.
Asunto(s)
Enfermedades Cardiovasculares/terapia , Diabetes Mellitus/terapia , Antagonistas Adrenérgicos beta/uso terapéutico , Angina Inestable/diagnóstico , Angina Inestable/etiología , Angioplastia de Balón , Aspirina/uso terapéutico , Glucemia/metabolismo , Enfermedades Cardiovasculares/complicaciones , Puente de Arteria Coronaria , Complicaciones de la Diabetes , Humanos , Hiperglucemia/diagnóstico , Hiperglucemia/terapia , Insulina/uso terapéutico , Italia , Infarto del Miocardio/complicaciones , Infarto del Miocardio/terapia , Educación del Paciente como Asunto , Factores de RiesgoRESUMEN
Diabetes is a well known risk factor for the development of congestive heart failure. Epidemiological evidence in the community underscores the prevalence of left ventricular systolic dysfunction in diabetic patients as 2-fold with respect to non-diabetic ones, with half of them completely asymptomatic. Diastolic dysfunction in diabetic hearts, in comparison with non-diabetic, is even more frequent. The high prevalence has been explained by the frequent coexistence of an underlying diabetic cardiomyopathy, hypertension and ischemic heart disease. In these patients, the diabetic metabolic derangement, together with the early activation of sympathetic nervous system, induce a decrease of myocardial function. The activation of renin-angiotensin system results in an unfavorable cardiac remodeling. The progression from myocardial damage to overt dysfunction and heart failure is often asymptomatic for a long time and frequently undiagnosed and untreated. Currently, the widespread availability of echocardiography and possibly the use of cardiac natriuretic peptides, may allow for an earlier recognition of most of such patients. In heart failure, diabetic patients have a worse prognosis than non-diabetics. The available pharmacological treatments, such as ACE-inhibitors, beta-blockers and possibly angiotensin receptor blockers, togheter with a tight glycemic control, may be effective to reverse the remodeling process and prevent cardiovascular events. In order to identify most of the diabetic patients at risk of development of left ventricular dysfunction and to prevent its progression to overt heart failure, it seems important to elaborate a screening strategy in order to diagnose and treat most of diabetic patients with myocardial damage.
Asunto(s)
Complicaciones de la Diabetes , Insuficiencia Cardíaca , Disfunción Ventricular Izquierda , Complicaciones de la Diabetes/diagnóstico , Complicaciones de la Diabetes/epidemiología , Complicaciones de la Diabetes/etiología , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/etiología , Humanos , Disfunción Ventricular Izquierda/diagnóstico , Disfunción Ventricular Izquierda/epidemiología , Disfunción Ventricular Izquierda/etiologíaRESUMEN
Ischemia and infection are the most important factors affecting the prognosis of foot ulcerations in diabetic patients. To improve the outcome of these patients, it is necessary to aggressively treat 2 important pathologies--namely, occlusive arterial disease affecting the tibial and femoral arteries and infection of the ischemic diabetic foot. Each of these 2 conditions may lead to major limb amputation, and the presence of both critical limb ischemia (CLI) and acute deep infection is a major risk factor for lower-extremity amputation. Thus, the management of diabetic foot ulcers requires specific therapeutic approaches that vary significantly depending on whether foot lesions are complicated by infection and/or ischemia. A multidisciplinary team approach is the key to successful treatment of a diabetic foot ulcer: ischemic diabetic foot ulcers complicated by acute deep infection pose serious treatment challenges because high levels of skill, organization, accuracy, and timing of intervention are required to maximize the chances of limb salvage: these complex issues are better managed by a multidisciplinary clinical group.
Asunto(s)
Amputación Quirúrgica/métodos , Pie Diabético , Úlcera del Pie , Isquemia , Recuperación del Miembro/métodos , Infecciones de los Tejidos Blandos , Pie Diabético/fisiopatología , Pie Diabético/terapia , Manejo de la Enfermedad , Pie/irrigación sanguínea , Pie/cirugía , Úlcera del Pie/etiología , Úlcera del Pie/fisiopatología , Úlcera del Pie/terapia , Humanos , Isquemia/etiología , Isquemia/fisiopatología , Isquemia/terapia , Grupo de Atención al Paciente , Pronóstico , Infecciones de los Tejidos Blandos/etiología , Infecciones de los Tejidos Blandos/fisiopatología , Infecciones de los Tejidos Blandos/terapia , Tiempo de TratamientoRESUMEN
AIMS: To investigate the effect of combined treatment with angiotensin-converting enzyme inhibitors (ACE) and statins on mortality in diabetic patients with critical limb ischemia (CLI). METHODS: Prospective observational study of 553 consecutive diabetic patients admitted because of CLI followed for a mean of 2.2 years. All patients underwent peripheral revascularization and antithrombotic therapy was prescribed or continued and therapy with statin and ACE was recorded. Mortality from any cause was assessed and Kaplan-Meier analyses were performed to compare the relationship between survival and recorded variables. RESULTS: One hundred thirty-nine patients did not have therapy with statin or an ACE, 78 had therapy with statin without ACE, 164 had therapy with ACE without statin and 172 patients had therapy with both statin and ACE. One hundred thirty-six patients died, 45/139 with neither statin nor ACE, 40/164 with ACE only, 26/78 with statin only, and 25/172 with both statin and ACE. Multivariate analysis confirmed the independent role of age, history of stroke, renal insufficiency and dialysis. Combined treatment with ACE and statin appeared to have a protective role. CONCLUSIONS: In patients with diabetes and CLI mortality after two years is high. Life expectancy was better in patients receiving combined therapy with ACE and statin but not with therapy with only a statin or an ACE.