RESUMEN
We conducted a secondary data analysis to evaluate the association between annual foot exams and incident lower extremity amputations (LEA) among older veterans with diabetes during FY2007-FY2014. Older Veterans with at least one primary care provider visit each year (N = 664,162) and at least one foot exam each year (N = 72,892) and the overlap were identified from the 5 years prior to the study period of interest (FY2002-FY2006 (N = 71,122)). After excluding incident LEA related to cancer and trauma, 71,018 veterans (mean age +/- SD, % male) were included in the final cohort, which was followed from FY2007-FY2014 to evaluate the influence of subsequent annual foot exams and incident LEA. Consistent annual foot exams were protective for incident LEA in older veterans with diabetes, adjusted OR was 0.85 (97% CI: 0.74-0.96). Results indicate that adherence to annual foot exam guidelines can reduce incident LEA in older veterans with diabetes.
Asunto(s)
Diabetes Mellitus , Pie Diabético , Veteranos , Masculino , Humanos , Anciano , Femenino , Pie Diabético/diagnóstico , Pie Diabético/epidemiología , Pie Diabético/cirugía , Extremidad Inferior/cirugía , Amputación Quirúrgica , Factores de RiesgoRESUMEN
DECLARATION OF INTEREST: The authors have no conflicts of interest to declare.
Asunto(s)
Cuidados Paliativos , Cicatrización de Heridas , HumanosRESUMEN
AIM: Our objective was to assess whether increased duration of metformin therapy is associated with incident peripheral neuropathy (PN) in older Veterans with diabetes. METHODS: Using national Veterans Affairs registry data from 2002 to 2015, we examined Veterans (50 + years) with diabetes. Long-term metformin therapy was defined as prescription ≥ 500 mg/day, filled for ≥ 6 consecutive months. Metformin therapy duration was examined both as continuous and categorical measures. Incident PN was defined by medical chart review. We estimated unadjusted and adjusted (variables selecteda priori)odds ratios (OR) and 95% confidence intervals (CI) using logistic regression. RESULTS: The study included n = 210,004 individuals (mean ± SD: age: 66.2 ± 8.4 yrs, 96% male) prescribed metformin for 47.0 ± 34.0 months. Nineteen percent developed PN during follow-up. After adjusting for age, body mass index, duration of time receiving health care within the VA, smoking status, alcohol abuse, and vitamin B12 testing and treatment, the number of months of metformin treatment was associated with elevated odds for incident PN (aOR (metformin treatment - continuous) = 1.009 (95% CI = 1.009, 1.010); aOR (metformin treatment - categorical (ref: 6-<18 months): 18-<44.1 months = 1.57 (1.51-1.63), 44.1-<61 months = 2.05 (1.97-2.14), 61 + months = 2.69 (2.58-2.79), all p-values < 0.0001). CONCLUSION: Our study suggests that Veterans treated for at least 18 months with metformin are approximately 2-3 times more likely to develop PN than those treated at least six, but<18 months. Future studies are needed to determine whether the association we found may be due to a decline in vitamin B12 status following metformin initiation.
Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Neuropatías Diabéticas/epidemiología , Hipoglucemiantes/efectos adversos , Metformina/efectos adversos , Veteranos/estadística & datos numéricos , Anciano , Alcoholismo/epidemiología , Índice de Masa Corporal , Diabetes Mellitus Tipo 2/sangre , Neuropatías Diabéticas/etiología , Femenino , Humanos , Hipoglucemiantes/uso terapéutico , Modelos Logísticos , Masculino , Metformina/uso terapéutico , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Fumar/epidemiología , Factores de Tiempo , Vitamina B 12/sangre , Deficiencia de Vitamina B 12/inducido químicamente , Deficiencia de Vitamina B 12/epidemiologíaRESUMEN
Patients with wounds bear significant clinical, personal, and economic burdens yet complete wound healing is the only United States Food and Drug Administration (FDA) recognized primary clinical trial end point. The overall goal of this project is to work with FDA to expand the list of acceptable primary end points, recognizing that new and innovative treatments, devices, and drugs may not have complete healing as the focus. Part 1 of the project surveyed 628 wound care experts who identified and content-validated 15 end points most relevant to clinical practice and benefitting patients' lives as primary outcomes in clinical trials. Part 2 is focused on critical appraisal of the evidence in the wound care literature supporting FDA criteria to qualify these 15 end points as primary end points in clinical trials. Further research involved systematic review of the literature regarding the most promising end points. Forty volunteer, interdisciplinary, wound healing experts in fields related to the end points compiled evidence from systematic MEDLINE searches and society databases supporting the FDA criteria of reliability, clinical construct validity, capacity to detect concurrent or longitudinal change, and responder analysis. The search revealed 485 references involving over 462,000 subjects supporting FDA-required parameters for all 15 end points More than 50 references supported FDA-required parameters qualifying the following outcomes for use in clinical trials supporting interventions for FDA clearance: Pain reduction, Physical function and ambulation, Infection reduction, Time to heal, and Percent wound area reduction in 4-8 weeks. Among these, only Time to heal is currently recognized by the FDA as a primary wound outcome in clinical trials. These results suggest that wound science is already serving patients and professionals by improving these content-validated outcomes that merit regulatory consideration.
Asunto(s)
Atención a la Salud/organización & administración , Cicatrización de Heridas/fisiología , Infección de Heridas/prevención & control , Heridas y Lesiones/terapia , Determinación de Punto Final , Medicina Basada en la Evidencia , Humanos , Reproducibilidad de los Resultados , Estados Unidos , United States Food and Drug Administration , Heridas y Lesiones/microbiologíaRESUMEN
We report a case of calcaneal osteomyelitis that was surgically resected from a patient with diabetes and peripheral vascular disease. A 91-year-old male with history of type 2 diabetes, peripheral vascular disease, balloon angioplasty, and recent (2 months ago) stent of the superficial femoral artery presented to the emergency department with a left heel wound infection probed to bone. The patient reported having been on intravenous Zosyn for several months via an outside infectious disease provider for clinical suspicion of osteomyelitis, but noted no improvement. This report includes information regarding the clinical examination and imaging findings, which were used to assess this high-risk patient. Our patient underwent a partial calcanectomy and completed a 6-week course of intravenous antibiotics. The purpose of this case report is to illustrate limb preservation in a high-risk patient with compromised vascular supply who underwent a partial calcanectomy for treatment of calcaneal osteomyelitis. The patient underwent surgical resection of the calcaneus without complications and healed unremarkably with the ability to ambulate while wearing an ankle foot orthosis with a custom shoe. This report was authorized for publication as an educational report to contribute to generalizable knowledge and does not include any patient health information.