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

Acknowledgements Some of the data were presented as an abstract at the Diabetes UK Professional Conference in 2017. Diabetes data for Scotland are available for analysis by members of the Scottish Diabetes Research Network (SDRN) thanks to the hard work and dedication of NHS staff across Scotland who enter the data and people and organisations (the Scottish Care Information –Diabetes Collaboration (SCI-DC) Steering Group, the Scottish Diabetes Group, the Scottish Diabetes Survey Group, the managed clinical network managers and staff in each Health Board) involved in setting up, maintaining and overseeing SCI-DC. The SDRN receives core support from the Chief Scientist’s Office at the Scottish Government Health Department. Members of the Scottish Diabetes Research Network Epidemiology Group who do not qualify for authorship but who contributed to data collection include R. Lindsay (Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK); J. McKnight (Western General Hospital, Edinburgh, UK); S. Philip (Institute of Applied Health Sciences, University of Aberdeen, UK); Members of the Scottish Diabetes Research Network Epidemiology Group who do not qualify for authorship but who contributed to data management include L. Blackbourn (Institute of Genetics and Molecular Medicine, University of Edinburgh, UK); B. Farran (Institute of Genetics and Molecular Medicine, University of Edinburgh, UK); D. McAllister (Institute of Health and Wellbeing, University of Glasgow, UK); P. McKeigue (Usher Institute of Population Health Sciences, University of Edinburgh, UK); S. Read (Usher Institute of Population Health Sciences, University of Edinburgh, UK).Peer reviewedPublisher PD

Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial

BackgroundUlcers of the heel in diabetes are the source of considerable suffering and cost. In the absence of specific treatments, it has been suggested that removable, lightweight fibreglass heel casts may both promote healing and reduce discomfort and pain. The aim of the study is to assess the effectiveness and cost-effectiveness of fibreglass heel casts in the management of heel ulcers.Methods/DesignThis is an observer-blind, randomised controlled trial in which participants with diabetes and heel ulcers (NPUAP/EPUAP grades 2, 3 or 4 and present for 2 or more weeks) are randomised to receive either usual care plus lightweight fibreglass heel casts or usual care alone. Randomisation is undertaken by random number sequence generation incorporated as part of the electronic case record form, and is stratified by both ulcer area (less than versus equal to or greater than 1 cm2) and NPUAP/EPUAP grade. Participants are followed every two weeks until healing or for 24 weeks. The primary outcome measure is healing at or before 24 weeks and maintained for 4 weeks. Secondary outcomes include (i) ulcer-related outcomes: time to healing, change in ulcer area, minor and major amputation, secondary infection and (ii) patient-related outcomes: local pain, mood and function (EQ-5D), impact of the ulcer (Cardiff Wound Impact Schedule) and survival. Cost-effectiveness will be assessed using a decision analytic model to estimate costs from the perspective of the UK NHS and personal social services and health outcomes, including percent healing and Quality Adjusted Life Years gained.Safety will be documented as adverse and serious adverse device effects.DiscussionIf it is possible to confirm significant clinical benefit and/or cost-effectiveness, this would have direct implications for the management of this distressing and costly complication of diabete

A logística na cadeia de frio em Portugal: transporte de produtos perecíveis congelados

Trabalho Final de Mestrado para obtenção do grau de Mestre em Engenharia MecânicaEste trabalho é o resultado de uma dissertação de mestrado no âmbito do 2º ano de Mestrado em Energia, Refrigeração e Climatização do Instituto Superior de Engenharia de Lisboa, e vai desenvolver- se numa empresa que comercializa e distribui uma vasta gama de produtos originários do mar, com maior incidência no peixe congelado e marisco. No contexto atual da sociedade e face às exigências do mercado e dos Clientes, o transporte do produto congelado é um tema da atualidade e que reveste de importância crucial, uma vez que deve ser garantido que o produto perecível foi transportado dentro dos padrões legais de conservação e transporte e sem interrupção na cadeia logística. O principal objetivo do projeto foi identificar qual o método mais adequado de transporte rodoviário de produtos perecíveis congelados (peixe), e analisar a importância da minimização da variação da temperatura na gestão do transporte de produtos perecíveis (TPP), integrada na Supply Chain Management (SCM). Apurar quais as causas e as consequências das variações de temperatura e as medidas a implementar para minimizar o seu impacto, numa perspetiva logística. As medições das variações térmicas foram realizadas no interior da caixa isotérmica com o recurso a equipamentos de medição de temperatura, “Data Logger” e o “Termopar”, tendo sido coletados os dados que após análise foram produzidas as respetivas conclusões. De modo a avaliar esta temática foi elaborada uma revisão de literatura qualificada, base da em artigos científicos, livros da especialidade, teses e dissertações. O estudo foi realizado numa Empresa de dimensão média, localizada nos arredores de Lisboa, que realiza o transporte de peixe congelado e marisco. O referido estudo permitiu concluir que existem variações térmicas à medida que se aproxima do ponto de distribuição final e apresentadas soluções para a minimização deste problema.Abstract: This work aims is the resu lt of a master's thesis under the 2nd year of Master in Energy, Refrigeration and Air Conditioning of the Instituto Superior de Engenharia de Lisboa, and will develop a company that markets and distributes a wide range of products originating Sea, focusing on the frozen fish and seafood. In the current context of society and meet the demands of the market and customers, the transport of frozen product is a topical issue and of crucial importance, since it must be ensured that the perishable product has been transported within the legal conservation standards and transportation and rolling in the logistics chain. The main objective of the project was to identify the most appropriate method of road transport frozen perishable products (fish), and analyse the i mportance of minimizing the variation of temperature in the transport of perishables management (TPP), part of the Supply Chain Management (SCM). Which determine the causes and consequences of temperature changes and the measures to be implemented to minimize its impact on a logistics perspective. Measurements were made of the thermal variations within the isothermal box with the use of temperature measuring devices, " Data Logger" and "Thermocouple", the data having been collected which after analysis the respective conclusions were produced. In order to assess this issue was elaborated a qualified literature review based on scientific papers, specialty books, theses and dissertations. The study was performed in a medium- sized company located in the outskirt s of Lisbon, which transports frozen fish and seafood. The study concluded that there are temperature changes as it approaches the final distribution point and presented solutions to minimize this problem

Examining diabetic heel ulcers through an ecological lens: microbial community dynamics associated with healing and infection

Purpose: While some micro-organisms, such as Staphylococcus aureus, are clearly implicated in causing tissue damage in diabetic foot ulcers (DFUs), our knowledge of the contribution of the entire microbiome to clinical outcomes is limited. We profiled the microbiome of a longitudinal sample series of 28 people with diabetes and DFUs of the heel in an attempt to better characterize the relationship between healing, infection and the microbiome.Methodology: In total, 237 samples were analysed from 28 DFUs, collected at fortnightly intervals for 6 months or until healing. Microbiome profiles were generated by 16S rRNA gene sequence analysis, supplemented by targeted nanopore sequencing.Result/Key findings: DFUs which failed to heal during the study period (20/28, 71.4 %) were more likely to be persistently colonized with a heterogeneous community of micro-organisms including anaerobes and Enterobacteriaceae (log-likelihood ratio 9.56, P=0.008). During clinically apparent infection, a reduction in the diversity of micro-organisms in a DFU was often observed due to expansion of one or two taxa, with recovery in diversity at resolution. Modelling of the predicted species interactions in a single DFU with high diversity indicated that networks of metabolic interactions may exist that contribute to the formation of stable communities.Conclusion: Longitudinal profiling is an essential tool for improving our understanding of the microbiology of chronic wounds, as community dynamics associated with clinical events can only be identified by examining changes over multiple time points. The development of complex communities, particularly involving Enterobacteriaceae and strict anaerobes, may be contributing to poor outcomes in DFUs and requires further investigation

The LeucoPatch® system in the management of hard-to-heal diabetic foot ulcers: study protocol for a randomised controlled trial

Background: Diabetic foot ulcers are a common and severe complication of diabetes mellitus. Standard treatment includes debridement, offloading, management of infection and revascularisation where appropriate, although healing times may be long. The LeucoPatch® device is used to generate an autologous platelet-rich fibrin and leucocyte wound dressing produced from the patient's own venous blood by centrifugation, but without the addition of any reagents. The final product comprises a thin, circular patch composed predominantly of fibrin together with living platelets and leucocytes. Promising results have been obtained in non-controlled studies this system, but this now needs to be tested in a randomised controlled trial (RCT). If confirmed, the LeucoPatch® may become an important new tool in the armamentarium in the management of diabetic foot ulcers which are hard-to-heal. Methods: People with diabetes and hard-to-heal ulcers of the foot will receive either pre-specified good standard care or good standard care supplemented by the application of the LeucoPatch® device. The primary outcome will be the percentage of ulcers healed within 20 weeks. Healing will be defined as complete epithelialisation without discharge that is maintained for 4 weeks and is confirmed by an observer blind to randomisation group. Discussion: Ulcers of the foot are a major source of morbidity to patients with diabetes and costs to health care economies. The study population is designed to be as inclusive as possible with the aim of maximising the external validity of any findings. The primary outcome measure is healing within 20 weeks of randomisation and the trial also includes a number of secondary outcome measures. Among these are rate of change in ulcer area as a predictor of the likelihood of eventual healing, minor and major amputation of the target limb, the incidence of infection and quality of life. Trial registration: International Standard Randomised Controlled Trial, ISRCTN27665670. Registered on 5 July 2013

Evaluation of full scale shear performance of tension anchor foundations: Load displacement curves and failure criteria

One of the biggest challenges faced by the offshore wave and tidal energy industry is the high cost of constructing and installing offshore foundations. Foundations based on post tensioned pile anchors can be effectively proposed to tackle this issue. A series of full-scale direct shear tests were performed on-shore to evaluate the shear resistance of post-tensioned pile anchor foundations designed for securing tidal turbine devices to a rock seabed. We focused, in particular, on the primary shear resistance mechanism of post-tensioned anchors, by applying a vertical force which mobilizes, a frictional force able to resist horizontal thrusts. Different load paths, involving monotonic or cyclic loading, were applied; several configurations for the footing of the foundation were tested. The footing stress-displacement behavior and the stress conditions at sliding failure from a number of different testing configurations were compared and analyzed. A marked consistency with the shear performance of natural rock joints was identified. This allows the behavior of tension pile foundations subjected to substantial horizontal loads to be modelled using relationships developed for rock joints, widely available in the literature. Additionally, the results obtained from different tests were also collated considering the various configurations adopted for the foundation-rock system and the applied load paths, to identify the factors that affect the shear resistance of the foundation.

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

Background Diabetes–related lower limb amputations are associated with considerable morbidity and mortality and are usually preceded by foot ulceration. The available systematic reviews of aggregate data are compromised because the primary studies report both adjusted and unadjusted estimates. As adjusted meta-analyses of aggregate data can be challenging, the best way to standardise the analytical approach is to conduct a meta-analysis based on individual patient data (IPD). There are however many challenges and fundamental methodological omissions are common; protocols are rare and the assessment of the risk of bias arising from the conduct of individual studies is frequently not performed, largely because of the absence of widely agreed criteria for assessing the risk of bias in this type of review. In this protocol we propose key methodological approaches to underpin our IPD systematic review of prognostic factors of foot ulceration in diabetes. Review questions; 1. What are the most highly prognostic factors for foot ulceration (i.e. symptoms, signs, diagnostic tests) in people with diabetes? 2. Can the data from each study be adjusted for a consistent set of adjustment factors? 3. Does the model accuracy change when patient populations are stratified according to demographic and/or clinical characteristics? Methods MEDLINE and EMBASE databases from their inception until early 2012 were searched and the corresponding authors of all eligible primary studies invited to contribute their raw data. We developed relevant quality assurance items likely to identify occasions when study validity may have been compromised from several sources. A confidentiality agreement, arrangements for communication and reporting as well as ethical and governance considerations are explained. We have agreement from the corresponding authors of all studies which meet the eligibility criteria and they collectively possess data from more than 17000 patients. We propose, as a provisional analysis plan, to use a multi-level mixed model, using “study” as one of the levels. Such a model can also allow for the within-patient clustering that occurs if a patient contributes data from both feet, although to aid interpretation, we prefer to use patients rather than feet as the unit of analysis. We intend to only attempt this analysis if the results of the investigation of heterogeneity do not rule it out and the model diagnostics are acceptable. Discussion This review is central to the development of a global evidence-based strategy for the risk assessment of the foot in patients with diabetes, ensuring future recommendations are valid and can reliably inform international clinical guidelines

The variation in incidence of amputation throughout England

The incidence of major amputation in diabetes varies up to 10‐fold between primary care trusts (PCTs) in England. Historically, there have been concerns about the reliability of databases which are used to obtain such figures, but the available evidence suggests that the documented variation is likely to be real. While a high prevalence of ethnic minorities may contribute to the low incidence observed in some PCTs, it is also thought the variation may relate largely to the structure of available specialist services. This paper reviews the factors which need to be considered in exploring possible explanations for the variation which has been observed

Amputations and diabetes care: variation in practice

No abstract available