A Prospective Study of Predictors for Foot Ulceration in Type 2 Diabetes

Kästenbauer, T; Sauseng, S; Sokol, Gerald H.; Auinger, Martin; Irsigler, K

doi:10.7547/87507315-91-7-343

Cited by 62 publications

(99 citation statements)

References 23 publications

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“…Figure 5 shows that the distribution of diabetes duration per study was similar overall. HbA 1c was, on average, 8% in each study apart from the studies by Young et al 75 (11%), Kästenbauer et al 62 (10%) and Boyko et al…”

Section: Pattern Of Missingnessmentioning

confidence: 99%

“…60 In multivariate models, the effect of kidney problems was not consistent, being apparently protective against ulceration in some cases 5,61 but predictive in others, for example. 3,46,47,62 Again, it was decided to drop kidney problems from the primary model but retain it for secondary analyses.…”

Section: Chapter 4 Development Of the Modelmentioning

confidence: 99%

“…3,5,61,62,[72][73][74][75] Data from a ninth study 46,47 were made available to the Data Management Committee via Safe Haven, a data-management system. Finally, a 10th corresponding author was not granted permission to share the data from a cohort study by the Institutional Review Board 48 but was able to contribute to the meta-analysis by subjecting the data to the same analytical procedures as all other studies to provide estimates of effect, which could be incorporated into the final (meta) analysis.…”

Section: Development Of the Modelmentioning

confidence: 99%

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A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS)

Crawford

Cézard

Chappell

et al. 2015

Health Technol Assess

161

196

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BackgroundAnnual foot risk assessment of people with diabetes is recommended in national and international clinical guidelines. At present, these are consensus based and use only a proportion of the available evidence.ObjectivesWe undertook a systematic review of individual patient data (IPD) to identify the most highly prognostic factors for foot ulceration (i.e. symptoms, signs, diagnostic tests) in people with diabetes.Data sourcesStudies were identified from searches of MEDLINE and EMBASE.Review methodsThe electronic search strategies for MEDLINE and EMBASE databases created during an aggregate systematic review of predictive factors for foot ulceration in diabetes were updated and rerun to January 2013. One reviewer applied the IPD review eligibility criteria to the full-text articles of the studies identified in our literature search and also to all studies excluded from our aggregate systematic review to ensure that we did not miss eligible IPD. A second reviewer applied the eligibility criteria to a 10% random sample of the abstract search yield to check that no relevant material was missed. This review includes exposure variables (risk factors) only from individuals who were free of foot ulceration at the time of study entry and who had a diagnosis of diabetes mellitus (either type 1 or type 2). The outcome variable was incident ulceration.ResultsOur search identified 16 cohort studies and we obtained anonymised IPD for 10. These data were collected from more than 16,000 people with diabetes worldwide and reanalysed by us. One data set was kept for independent validation. The data sets contributing IPD covered a range of temporal, geographical and clinical settings. We therefore selected random-effects meta-analysis, which assumes not that all the estimates from each study are estimates of the same underlying true value, but rather that the estimates belong to the same distribution. We selected candidate variables for meta-analysis using specific criteria. After univariate meta-analyses, the most clinically important predictors were identified by an international steering committee for inclusion in the primary, multivariable meta-analysis. Age, sex, duration of diabetes, monofilaments and pulses were considered most prognostically important. Meta-analyses based on data from the entire IPD population found that an inability to feel a 10-g monofilament [odds ratio (OR) 3.184, 95% confidence interval (CI) 2.654 to 3.82], at least one absent pedal pulse (OR 1.968, 95% CI 1.624 to 2.386), a longer duration of a diagnosis of diabetes (OR 1.024, 95% CI 1.011 to 1.036) and a previous history of ulceration (OR 6.589, 95% CI 2.488 to 17.45) were all predictive of risk. Female sex was protective (OR 0.743, 95% CI 0.598 to 0.922).LimitationsIt was not possible to perform a meta-analysis using a one-step approach because we were unable to procure copies of one of the data sets and instead accessed data via Safe Haven.ConclusionsThe findings from this review identify risk assessment procedures that can reliably inform national and international diabetes clinical guideline foot risk assessment procedures. The evidence from a large sample of patients in worldwide settings show that the use of a 10-g monofilament or one absent pedal pulse will identify those at moderate or intermediate risk of foot ulceration, and a history of foot ulcers or lower-extremity amputation is sufficient to identify those at high risk. We propose the development of a clinical prediction rule (CPR) from our existing model using the following predictor variables: insensitivity to a 10-g monofilament, absent pedal pulses and a history of ulceration or lower-extremities amputations. This CPR could replace the many tests, signs and symptoms that patients currently have measured using equipment that is either costly or difficult to use.Study registrationThis study is registered as PROSPERO CRD42011001841.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Pattern Of Missingnessmentioning

confidence: 99%

Section: Chapter 4 Development Of the Modelmentioning

confidence: 99%

Section: Development Of the Modelmentioning

confidence: 99%

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A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS)

Crawford

Cézard

Chappell

et al. 2015

Health Technol Assess

161

196

View full text Add to dashboard Cite

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“…Visual acuity 76 (poor vision) score [10] and VPT score [12] (measure of neu-77 ropathy level) were reported to be associated with DFU. monly used predicting the risk of ulceration [14].…”

mentioning

confidence: 99%

“…Diabetes mellitus (type 2) is the most frequent cause of 72 Furthermore other readily identifiable parameters like age [7] 73 and duration of diabetes [5] height [11], body weight [12] and 74 Body Mass Index (BMI) [13] have been associated with ulcera-75 tion risk in patients with diabetic neuropathy. Visual acuity 76 (poor vision) score [10] and VPT score [12] (measure of neu-77 ropathy level) were reported to be associated with DFU.…”

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confidence: 99%

Can plantar soft tissue mechanics enhance prognosis of diabetic foot ulcer?

Naemi

Chatzistergos

Suresh

et al. 2017

Diabetes Research and Clinical Practice

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Epidemiology and Economic Impact of Foot Ulcers

LeMaster

Reiber

2006

The Foot in Diabetes

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In the year 2005, most of the estimated 150 million people worldwide afflicted by diabetes mellitus lived in developing countries.1 Diabetic foot ulcers will complicate the disease in more than 15% of these people during their lifetimes. 2,3 In prospective cohort studies conducted among those with diabetes, history of a foot ulcer increased the risk of subsequent amputation by two-to over three-fold. 4,5 Foot ulcers precede more than 80% of non-traumatic lower limb amputations. 6 In this chapter, we will review the definition of a 'foot ulcer' and the studies that estimate the incidence and prevalence of foot ulcers, making note of issues that need to be considered in their computation. We will also review risk factors for foot ulcers from wellconducted epidemiological studies, foot ulcer outcomes and the economic impact of foot ulcers. FOOT ULCER DEFINITION AND CLASSIFICATIONIn order to estimate accurately the occurrence of diabetic foot ulcers and risk factors associated with this diabetic complication, a common definition is needed. The International Consensus on the Diabetic Foot currently defines a diabetic foot ulcer as a full-thickness wound below the ankle in a patient with diabetes, irrespective of duration. 7 The International Working Group on the Diabetic Foot (IWGDF) also recommends that studies describing the occurrence of diabetic foot ulcers use a standard classification system to facilitate communication between health care providers, provide information about the healing potential of an ulcer and help guide management decisions. Use of such a system allows a patient to be followed up over time, allowing repeated classification of the foot ulcer. Classification systems should be sufficiently robust that intra-and inter-observer variability is low (i.e. the classification is reproducible) and should be applicable worldwide. This allows research results from one study to be compared to those of others, which is important in interpretability of results.8 For foot ulcers, one challenge in this regard has been the numerous classification systems in existence. The most commonly used system internationally is Wagner's.9 This system specifies ulcer depth and the presence of osteomyelitis or gangrene as a five-grade continuum:Grade 0 Pre-ulcerative lesion Grade 1 Partial-thickness wound up to but not through the dermis

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A Prospective Study of Predictors for Foot Ulceration in Type 2 Diabetes

Cited by 62 publications

References 23 publications

A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS)

A systematic review and individual patient data meta-analysis of prognostic factors for foot ulceration in people with diabetes: the international research collaboration for the prediction of diabetic foot ulcerations (PODUS)

Can plantar soft tissue mechanics enhance prognosis of diabetic foot ulcer?

Epidemiology and Economic Impact of Foot Ulcers

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