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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: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.

Project description:AbstractLower limb amputation (LLA) is still a health issue requiring rehabilitation and long-term care even in industrial societies. Several studies on subjects with LLA have been focused on the efficacy of rehabilitation and factors influencing the use of prosthesis. However, literature data on the recovery of ability to walk outdoors, and thus to participate in social life in this population is limited.To investigate potential correlations between socio-demographic and clinical factors, and the use of the prosthesis for indoor and/or outdoor walking referred to as community ambulation (CA) in subjects with LLA.An observational cohort study on 687 LLA subjects was conducted. Socio-demographic and clinical characteristics of 302 subjects who received similar rehabilitative treatment with respect to the standard protocol were collected by a telephone survey with a structured questionnaire. The CA recovery, in terms of patient's autonomy and participation, assessed by Walking Handicap Scale, was considered as the main outcome.The univariate analysis demonstrated statistical significant positive correlation between CA and gender (χ2 = 3.901, P = .048); amputation level (χ2 = 24.657, P < .001); pre-LLA (χ2 = 6.338, P = .012) and current work activity (χ2 = 25.192, P < .001); prosthesis use (χ2 = 187.037, P < .01); and time from LLA (r = 0.183, P < .001); increasing age was negatively correlated with the outcome (r = -0.329, P < .001), while pain intensity was not significant. Being male (75.4%); trans-tibial (TT) amputation level (9.79%); working before (3.81%) and after LLA (7.68%); and the prosthesis use (24.63%) increased the probability of CA recovery. Multivariate binary logistic regression analysis confirmed that the prosthesis use (P < .001) and TT amputation level (P = .042) are predictors of a positive outcome (Walking Handicap Scale 4-6).These findings highlight the importance of the use of prosthesis in people with LLA for the restoration of a good capacity of participation (CA), especially in subjects with TT amputation level. The identification of predictive factors may help tailor-made rehabilitation approaches addressing an earlier reintegration to social life.

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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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