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Amputation-free survival in 17,353 people at high risk for foot ulceration in diabetes: a national observational study.

ABSTRACT: AIMS/HYPOTHESIS:Our aim was to investigate amputation-free survival in people at high risk for foot ulceration in diabetes ('high-risk foot'), and to compare different subcategories of high-risk foot. METHODS:Overall, 17,353 people with diabetes and high-risk foot from January 2008 to December 2011 were identified from the Scotland-wide diabetes register (Scottish Care Information-Diabetes: N?=?247,278). Participants were followed-up for up to 2 years from baseline and were categorised into three groups: (1) those with no previous ulcer, (2) those with an active ulcer or (3) those with a healed previous ulcer. Participants with prior minor or major amputation were excluded. Accelerated failure time models were used to compare amputation-free survival up to 2 years between the three exposure groups. RESULTS:The 2 year amputation-free survival rate in all people with diabetes with high-risk foot was 84.5%. In this study group, 270 people (10.0%) had an amputation and 2424 (90.0%) died during the 2 year follow-up period. People who had active and healed previous ulcers at baseline had significantly lower 2 year amputation-free survival compared with those who had no previous ulcer (both p?

SUBMITTER: Vadiveloo T

PROVIDER: S-EPMC6223842 | biostudies-other | 2018 Dec

REPOSITORIES: biostudies-other

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Amputation-free survival in 17,353 people at high risk for foot ulceration in diabetes: a national observational study.

Vadiveloo Thenmalar T Jeffcoate William W Donnan Peter T PT Colhoun Helen C HC McGurnaghan Stuart S Wild Sarah S McCrimmon Rory R Leese Graham P GP

Diabetologia 20180831 12

<h4>Aims/hypothesis</h4>Our aim was to investigate amputation-free survival in people at high risk for foot ulceration in diabetes ('high-risk foot'), and to compare different subcategories of high-risk foot.<h4>Methods</h4>Overall, 17,353 people with diabetes and high-risk foot from January 2008 to December 2011 were identified from the Scotland-wide diabetes register (Scottish Care Information-Diabetes: N = 247,278). Participants were followed-up for up to 2 years from baseline and were catego ...[more]

PMID: 30171278

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Project description:AimsRisk factors for lower limb amputation (LLA) in individuals with diabetes have been under-studied. We examined how 1/demographic and socioeconomic, 2/medical, and 3/lifestyle risk factors may be associated with LLA in people with newly diagnosed diabetes.MethodsUsing the Swedish national diabetes register from 2007 to 2016, we identified all individuals ≥18 years with an incident diabetes diagnosis and no previous amputation. These individuals were followed from the date of diabetes diagnosis to amputation, emigration, death, or the end of the study in 2017 using data from the In-Patient Register and the Total Population Register. The cohort consisted of 66,569 individuals. Information about demographic, socioeconomic, medical, and lifestyle risk factors was ascertained around the time of the first recorded diabetes diagnosis, derived from the above-mentioned registers. Cox proportional hazard models were used to obtain hazard ratios (HR) with 95% confidence intervals (CI).ResultsDuring the median follow-up time of 4 years, there were 133 individuals with LLA. The model adjusting for all variables showed a higher risk for LLA with higher age, HR 1.08 (95% CI 1.05-1.10), male sex, HR 1.57 (1.06-2.34), being divorced, HR 1.67 (1.07-2.60), smokers HR 1.99 (1.28-3.09), insulin treated persons HR 2.03 (1.10-3.74), people with low physical activity (PA) HR 2.05 (1.10-3.74), and people with an increased foot risk at baseline HR > 4.12. People with obesity had lower risk, HR 0.46 (0.29-0.75).ConclusionsThis study found a higher risk for LLA among people with higher age, male sex, who were divorced, had a higher foot risk group, were on insulin treatment, had lower PA levels, and were smokers. No significant association was found between risk for LLA and education level, country of origin, type of diabetes, blood glucose level, hypertension, hyperlipidemia, creatinine level, or glomerular filtration rate. Obesity was associated with lower risk for LLA. Identified variables may have important roles in LLA risk among people with diabetes.

Project description:BACKGROUND:Diabetes mellitus is a major global health issue with a growing prevalence. In this context, the number of diabetic complications is also on the rise, such as diabetic foot ulcers (DFU), which are closely linked to the risk of lower extremity amputation (LEA). Statistical prediction tools may support clinicians to initiate early tertiary LEA prevention for DFU patients. Thus, we designed Bayesian prediction models, as they produce transparent decision rules, quantify uncertainty intuitively and acknowledge prior available scientific knowledge. METHOD:A logistic regression using observational collected according to the standardised PEDIS classification was utilised to compute the six-month amputation risk of DFU patients for two types of LEA: 1.) any-amputation and 2.) major-amputation. Being able to incorporate information which is available before the analysis, the Bayesian models were fitted following a twofold strategy. First, the designed prediction models waive the available information and, second, we incorporated the a priori available scientific knowledge into our models. Then, we evaluated each model with respect to the effect of the predictors and validity of the models. Next, we compared the performance of both models with respect to the incorporation of prior knowledge. RESULTS:This study included 237 patients. The mean age was 65.9 (SD 12.3), and 83.5% were male. Concerning the outcome, 31.6% underwent any- and 12.2% underwent a major-amputation procedure. The risk factors of perfusion, ulcer extent and depth revealed an impact on the outcomes, whereas the infection status and sensation did not. The major-amputation model using prior information outperformed the uninformed counterpart (AUC 0.765 vs AUC 0.790, Cohen's d 2.21). In contrast, the models predicting any-amputation performed similarly (0.793 vs 0.790, Cohen's d 0.22). CONCLUSIONS:Both of the Bayesian amputation risk models showed acceptable prognostic values, and the major-amputation model benefitted from incorporating a priori information from a previous study. Thus, PEDIS serves as a valid foundation for a clinical decision support tool for the prediction of the amputation risk in DFU patients. Furthermore, we demonstrated the use of the available prior scientific information within a Bayesian framework to establish chains of knowledge.

Project description:Research Question: Previous cross-sectional studies have shown an association between sudomotor dysfunction and diabetic foot ulceration (DFU). The aim of this prospective multicenter study was to determine the role of dryness of foot skin and of established neurological modalities in the prediction of risk for foot ulceration in a cohort of individuals with diabetes mellitus (DM). Design: The study was conducted from 2012 to 2017. A total of 308 subjects with DM without history of DFU or critical limb ischemia completed the study. Diabetic neuropathy was assessed using the neuropathy symptom score (NSS) and neuropathy disability score (NDS). In a subset of participants, vibration perception threshold (VPT) was evaluated. Dryness of foot skin was assessed by the visual indicator plaster method (IPM). The diagnostic performance of the above neurological modalities for prediction of DFU was tested by receiver operating characteristic curve (ROC) analysis. Results: During the 6-year follow-up, 55 patients (annual ulceration incidence 2.97%) developed DFU. Multivariate Cox-regression analysis after controlling for the effect of age, gender, and DM duration demonstrated that the risk (hazard ratio, 95% confidence intervals) of DFU increased significantly with either abnormal IPM (3.319, 1.460-7.545, p = 0.004) or high (≥6) NDS (2.782, 1.546-5.007, p = 0.001) or high (≥25 volts) VPT (2.587, 1.277-5.242, p = 0.008). ROC analysis showed that all neurological modalities could discriminate participants who developed DFU (p < 0.001). IPM testing showed high sensitivity (0.86) and low specificity (0.49), while high vs. low NDS and VPT showed low sensitivity (0.40 and 0.39, respectively) and high specificity (0.87 and 0.89, respectively) for identification of patients at risk for DFU. Conclusion: Dryness of foot skin assessed by the IPM predicts the development of DFU. IPM testing has high sensitivity, whereas high NDS and VPT have high specificity in identifying subjects at risk for DFU. The IPM can be included in the screening methods for identification of the foot at risk.

Project description:AimsElevated dynamic plantar pressures are a consistent finding in diabetes patients with peripheral neuropathy with implications for plantar foot ulceration. This meta-analysis aimed to compare the plantar pressures of diabetes patients that had peripheral neuropathy and those with neuropathy with active or previous foot ulcers.MethodsPublished articles were identified from Medline via OVID, CINAHL, SCOPUS, INFORMIT, Cochrane Central EMBASE via OVID and Web of Science via ISI Web of Knowledge bibliographic databases. Observational studies reporting barefoot dynamic plantar pressure in adults with diabetic peripheral neuropathy, where at least one group had a history of plantar foot ulcers were included. Interventional studies, shod plantar pressure studies and studies not published in English were excluded. Overall mean peak plantar pressure (MPP) and pressure time integral (PTI) were primary outcomes. The six secondary outcomes were MPP and PTI at the rear foot, mid foot and fore foot. The protocol of the meta-analysis was published with PROPSERO, (registration number CRD42013004310).ResultsEight observational studies were included. Overall MPP and PTI were greater in diabetic peripheral neuropathy patients with foot ulceration compared to those without ulceration (standardised mean difference 0.551, 95% CI 0.290-0.811, p<0.001; and 0.762, 95% CI 0.303-1.221, p = 0.001, respectively). Sub-group analyses demonstrated no significant difference in MPP for those with neuropathy with active ulceration compared to those without ulcers. A significant difference in MPP was found for those with neuropathy with a past history of ulceration compared to those without ulcers; (0.467, 95% CI 0.181- 0.753, p = 0.001). Statistical heterogeneity between studies was moderate.ConclusionsPlantar pressures appear to be significantly higher in patients with diabetic peripheral neuropathy with a history of foot ulceration compared to those with diabetic neuropathy without a history of ulceration. More homogenous data is needed to confirm these findings.

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Amputation-free survival in 17,353 people at high risk for foot ulceration in diabetes: a national observational study.

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Amputation-free survival in 17,353 people at high risk for foot ulceration in diabetes: a national observational study.

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