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INTRODUCTION: This study aimed to determine the relationship between HbA1c variability and foot ulcer healing at 12 weeks and 12 months. METHODS: Using National Diabetic Foot Care Audit (NDFA) and hospital records, demographics, baseline ulcer characteristics and healing outcomes for subjects presenting with a foot ulcer between 2017-2022 were collected at 12 weeks and 12 months. Subjects had diabetes duration > 3 years and ≥ 3 HbA1c recordings in the 5 years prior to presentation. RESULTS: At 12 weeks, factors associated with an active ulcer were presence on hind foot (adjusted odds ratios) (2.1 [95% CI 1.3-3.7]), ischaemia (2.1 [95% CI:1.4-3.2]), area > 1 cm2 (2.7 [95% CI:1.7-4.2]) and diabetes duration > 24 years vs 3-10 (AOR 2.0 [95% CI 1.2-3.5]). After adjustment, HbA1c variability 6-10 mmol/mol and > 14.5 mmol/mol had AOR of 1.76 (95% CI 1.1-2.8; p = 0.0192) and 1.5 (95% CI 0.9-2.6; p = 0.1148) of an active ulcer at 12 weeks vs variability < 6 mmol/mol. At 12 months, ischaemia (AOR 2.4 [95% CI 1.5-3.8]) and diabetes duration > 24 years vs 3-10 years (AOR 3.3 [95% CI 1.7-6.4] were significant factors. HbA1c variability was not significant at 12 months. CONCLUSION: In keeping with the national NDFA data, in our cohort ulcer characteristics, but not HbA1c variability, were the key factors associated with ulcer healing at 12 weeks and 12 months.
Diabetes complications occur more frequently when glucose control is not as good as it could be. For a long time, HbA1c, or glycated haemoglobin, has been used as a measure of how well someone's diabetes has been controlled. However, another way of looking at diabetes control is to look at the changes of HbA1c over timethis is called glycaemic variability. Diabetes-related foot disease is one of the most feared complications of the condition, and our group has previously shown in a small study that glycaemic variability was associated with ulcer healing at 12 weekswith lower variability leading to better healing. However, it did not consider other variables known to be associated with not being alive and ulcer free at 12 months. In the UK, data are collected as part of the National Diabetes Footcare Audit (NDFA). This dataset collects a lot of information on new foot ulcers and their outcomes 12 weeks later. We have used our centre's data to look at factors not included in the NDFA datasetin particular glycaemic variabilityto determine whether this influences ulcer outcomes at 12 weeks, but also at 12 months. We found that low glycaemic variability is associated with greater chances of healing but that the greatest association is the presence of poor blood flow and diabetes duration.
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Background: Charcot neuro-osteoarthropathy (CNO) is a rare but devastating complication of diabetes associated with high rates of morbidity; yet, many nonfoot specialists are unaware of it, resulting in missed and delayed diagnosis. Clinical practice guidelines (CPGs) have proven useful in improving quality of care and standardizing practice in diabetes and diabetic foot care. However, little is known about the consistency in recommendations for identification and management of active CNO. Aim: The aim of this study is to review European national diabetes CPGs for the diagnosis and management of active CNO and to assess their methodological rigor and transparency. Methods: A systematic search was performed to identify diabetes national CPGs across Europe. Guidelines in any language were reviewed to explore whether they provided a definition for active CNO and recommendations for diagnosis, monitoring, and management. Methodological rigor and transparency were assessed using the Appraisal of Guidelines for Research and Evaluation (AGREE-II) tool, which comprises 23 key items organized within six domains with an overall guideline assessment score of ≥ 60% considered to be of adequate quality to recommend use. Each guideline was assessed by two reviewers, and inter-rater agreement (Kendall's W) was calculated for AGREE-II scores. Results: Seventeen CPGs met the inclusion criteria. Breadth of CNO content varied across guidelines (median (IQR) word count: 327; Q1 = 151; Q3 = 790), and 53% provided a definition for active CNO. Recommendations for diagnosis and monitoring were provided by 82% and 53%, respectively, with offloading being the most common management recommendation (88%). Four guidelines (24%) reached threshold for recommendation for use in clinical practice (≥ 60%) with the scope and purpose domain scoring highest (mean (SD): 67%, ± 23%). The remaining domains had average scores ranging between 19% and 53%. Inter-rater agreement was strong (W = 0.882; p < 0.001). Conclusions: European national CPGs for diabetes provide limited recommendations on active CNO. All guidelines showcased deficits in their methodology, suggesting that more rigorous methods should be employed for diabetes CPG development across Europe.
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Artropatía Neurógena , Guías de Práctica Clínica como Asunto , Humanos , Europa (Continente) , Artropatía Neurógena/terapia , Artropatía Neurógena/diagnóstico , Medicina Basada en la Evidencia , Pie Diabético/terapia , Pie Diabético/diagnóstico , Neuropatías Diabéticas/terapia , Neuropatías Diabéticas/diagnósticoRESUMEN
AIMS/HYPOTHESIS: The risk of dying within 2 years of presentation with diabetic foot ulceration is over six times the risk of amputation, with CVD the major contributor. Using an observational evaluation of a real-world implementation pilot, we aimed to assess whether for those presenting with diabetic foot ulceration in England, introducing a 12-lead ECG into routine care followed by appropriate clinical action was associated with reduced mortality. METHODS: Between July 2014 and December 2017, ten multidisciplinary diabetic foot services in England participated in a pilot project introducing 12-lead ECGs for new attendees with foot ulceration. Inception coincided with launch of the National Diabetes Footcare Audit (NDFA), whereby all diabetic footcare services in England were invited to enter data on new attendees with foot ulceration. Poisson regression models assessed the mortality RR at 2 and 5 years following first assessment of those receiving care in a participating pilot unit vs those receiving care in any other unit in England, adjusting for age, sex, ethnicity, deprivation, type and duration of diabetes, ulcer severity, and morbidity in the year prior to first assessment. RESULTS: Of the 3110 people recorded in the NDFA at a participating unit during the pilot, 33% (1015) were recorded as having received an ECG. A further 25,195 people recorded in the NDFA had attended another English footcare service. Unadjusted mortality in the pilot units was 16.3% (165) at 2 years and 37.4% (380) at 5 years for those who received an ECG, and 20.5% (430) and 45.2% (950), respectively, for those who did not receive an ECG. For people included in the NDFA at other units, unadjusted mortality was 20.1% (5075) and 42.6% (10,745), respectively. In the fully adjusted model, mortality was not significantly lower for those attending participating units at 2 (RR 0.93 [95% CI 0.85, 1.01]) or 5 years (RR 0.95 [95% CI 0.90, 1.01]). At participating units, mortality in those who received an ECG vs those who did not was lower at 5 years (RR 0.86 [95% CI 0.76, 0.97]), but not at 2 years (RR 0.87 [95% CI 0.72, 1.04]). Comparing just those that received an ECG with attendees at all other centres in England, mortality was lower at 5 years (RR 0.87 [95% CI 0.78, 0.96]), but not at 2 years (RR 0.86 [95% CI 0.74, 1.01]). CONCLUSIONS/INTERPRETATION: The evaluation confirms the high mortality seen in those presenting with diabetic foot ulceration. Overall mortality at the participating units was not significantly reduced at 2 or 5 years, with confidence intervals just crossing parity. Implementation of the 12-lead ECG into the routine care pathway proved challenging for clinical teams-overall a third of attendees had one, although some units delivered the intervention to over 60% of attendees-and the evaluation was therefore underpowered. Nonetheless, the signals of potential mortality benefit among those who had an ECG suggest that units in a position to operationalise implementation may wish to consider this. DATA AVAILABILITY: Data from the National Diabetes Audit can be requested through the National Health Service Digital Data Access Request Service process at: https://digital.nhs.uk/services/data-access-request-service-dars/dars-products-and-services/data-set-catalogue/national-diabetes-audit-nda.
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Pie Diabético , Electrocardiografía , Humanos , Pie Diabético/mortalidad , Femenino , Masculino , Inglaterra/epidemiología , Anciano , Proyectos Piloto , Persona de Mediana Edad , Amputación Quirúrgica/estadística & datos numéricosRESUMEN
The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This is the first guideline on the diagnosis and treatment of active Charcot neuro-osteoarthropathy in persons with diabetes published by the IWGDF. We followed the GRADE Methodology to devise clinical questions in the PACO (Population, Assessment, Comparison, Outcome) and PICO (Population, Intervention, Comparison, Outcome) format, conducted a systematic review of the medical literature, and developed recommendations with the rationale. The recommendations are based on the evidence from our systematic review, expert opinion when evidence was not available, and also taking into account weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to an intervention. We here present the 2023 Guidelines on the diagnosis and treatment of active Charcot neuro-osteoarthropathy in persons with diabetes mellitus and also suggest key future topics of research.
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Artropatía Neurógena , Diabetes Mellitus , Pie Diabético , Humanos , Pie Diabético/diagnóstico , Pie Diabético/etiología , Pie Diabético/terapia , Artropatía Neurógena/complicaciones , Artropatía Neurógena/diagnósticoRESUMEN
AIMS: Offloading mechanical tissue stress is arguably the most important of multiple interventions needed to heal diabetes-related foot ulcers. This is the 2023 International Working Group on the Diabetic Foot (IWGDF) evidence-based guideline on offloading interventions to promote healing of foot ulcers in persons with diabetes. It serves as an update of the 2019 IWGDF guideline. MATERIALS AND METHODS: We followed the GRADE approach by devising clinical questions and important outcomes in the PICO (Patient-Intervention-Control-Outcome) format, undertaking a systematic review and meta-analyses, developing summary of judgement tables and writing recommendations and rationales for each question. Each recommendation is based on the evidence found in the systematic review, expert opinion where evidence was not available, and a careful weighing of GRADE summary of judgement items including desirable and undesirable effects, certainty of evidence, patient values, resources required, cost effectiveness, equity, feasibility, and acceptability. RESULTS: For healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, use a non-removable knee-high offloading device as the first-choice offloading intervention. If contraindications or patient intolerance to non-removable offloading exist, consider using a removable knee-high or ankle-high offloading device as the second-choice offloading intervention. If no offloading devices are available, consider using appropriately fitting footwear combined with felted foam as the third-choice offloading intervention. If such a non-surgical offloading treatment fails to heal a plantar forefoot ulcer, consider an Achilles tendon lengthening, metatarsal head resection, joint arthroplasty, or metatarsal osteotomy. For healing a neuropathic plantar or apex lesser digit ulcer secondary to flexibile toe deformity, use digital flexor tendon tenotomy. For healing rearfoot, non-plantar or ulcers complicated with infection or ischaemia, further recommendations have been outlined. All recommendations have been summarised in an offloading clinical pathway to help facilitate the implementation of this guideline into clinical practice. CONCLUSION: These offloading guideline recommendations should help healthcare professionals provide the best care and outcomes for persons with diabetes-related foot ulcers and reduce the person's risk of infection, hospitalisation and amputation.
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Diabetes Mellitus , Pie Diabético , Úlcera del Pie , Humanos , Pie Diabético/etiología , Pie Diabético/terapia , Úlcera , Úlcera del Pie/terapia , Pie , Cicatrización de HeridasRESUMEN
BACKGROUND: There are uncertainties regarding the diagnostic criteria, optimal treatment methods, interventions, monitoring and determination of remission of Charcot neuro-osteoarthropathy (CNO) of the foot and ankle in people with diabetes mellitus (DM). The aims of this systematic review are to investigate the evidence for the diagnosis and subsequent treatment, to clarify the objective methods for determining remission and to evaluate the evidence for the prevention of re-activation in people with CNO, DM and intact skin. METHODS: We performed a systematic review based on clinical questions in the following categories: Diagnosis, Treatment, Identification of Remission and Prevention of Re-Activation in people with CNO, DM and intact skin. Included controlled studies were assessed for methodological quality and key data from all studies were extracted. RESULTS: We identified 37 studies for inclusion in this systematic review. Fourteen retrospective and observational studies relevant to the diagnosis of active CNO with respect to clinical examination, imaging and blood laboratory tests in patients with DM and intact skin were included. We identified 18 studies relevant to the treatment of active CNO. These studies included those focused on offloading (total contact cast, removable/non-removable knee high devices), medical treatment and surgical treatment in the setting of active CNO. Five observational studies were identified regarding the identification of remission in patients who had been treated for active CNO. We did not identify any studies that met our inclusion criteria for the prevention of re-activation in patients with DM and intact skin who had been previously treated for active CNO and were in remission. CONCLUSIONS: There is a paucity of high-quality data on the diagnosis, treatment, and prognosis of active CNO in people with DM and intact skin. Further research is warranted to address the issues surrounding this complex disease.
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Artropatía Neurógena , Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Pie Diabético , Humanos , Pie Diabético/diagnóstico , Pie Diabético/etiología , Pie Diabético/terapia , Estudios Retrospectivos , Pronóstico , Artropatía Neurógena/complicaciones , Artropatía Neurógena/diagnósticoRESUMEN
Charcot neuroarthropathy (CN) was first described over 150 years ago. Despite this there remains uncertanity around the factors that contribute to its development, and progression. This article will discuss the current controversies around the pathogenesis, epidemiology, diagnosis, assessment and management of the condition. The exact pathogenesis of CN is not fully understood, and it is likely to be multifactorial, with perhaps currently unknown mechanisms contributing to its development. Further studies are needed to examine opportunities to help screen for and diagnose CN. As a result of many of these factors, the true prevalence of CN is still largely unknown. Almost all of the recommendations for the assessment and treatment of CN are based on low-quality level III and IV evidence. Despite recommendations to offer people with CN nonremovable devices, currently only 40-50% people are treated with this type of device. Evidence is also lacking about the optimal duration of treatment; reported outcomes range from 3 months to more than a year. The reason for this variation is not entirely clear. A lack of standardised definitions for diagnosis, remission and relapse, heterogeneity of populations, different management approaches, monitoring techniques with unknown diagnostic precision and variation in follow-up times prevent meaningful comparison of outcome data. If people can be better supported to manage the emotional and physical consequences of CN, then this could improve people's quality of life and well-being. Finally, we highlight the need for an internationally coordinated approach to research in CN.
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AIMS: To assess annual change in prevalence of methicillin resistant Staphylococcus aureus (MRSA) from tissue and wound swab samples from foot ulcers (DFUs) in people with diabetes between 2005 and 2021. METHODS: A retrospective analysis of everyone with MRSA positive wound or tissue swabs taken from our specialist multidisciplinary foot clinic between July 2005 and July 2021. RESULTS: A total of 406 MRSA positive isolates from DFU swabs were identified from 185 individuals attending the foot clinic. There were 22 hospital-acquired infections (HAIs) and 159 community-acquired infections (CAIs). Fifty-two per cent (n = 37) of these individuals from 2010 to 2021 (n = 71) had presence of at least three risk factors for MRSA. The total number of swabs sent was 6312 from 1916 individuals living with diabetes. Annual MRSA DFU prevalence peaked in 2008 at 14.6% (n = 38), decreased in 2013 to 5.2% (n = 20) and did not exceed 4% (n = 6) from 2015 to 2021. Hospital MRSA was lowest in 2021 (n = 211), a 76% fall from 2007 (n = 880). Incidence of MRSA HAI from 2015 to 2021 ranged from 5.4% (n = 14) in 2020 to 11.5% (n = 41) in 2018. CONCLUSIONS: Prevalence of MRSA in DFU infections treated as outpatients is decreasing in line with falls in hospital acquired blood-borne infections and with overall hospital MRSA incidence. This is likely a reflection of the combination of interventions, including stringent antibiotic prescribing and decolonisation strategies. Reduction in prevalence should have positive impact on outcomes in people living with diabetes, reducing the complication of osteomyelitis and necessity for long-term antibiotic administration.
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Diabetes Mellitus , Pie Diabético , Staphylococcus aureus Resistente a Meticilina , Infecciones Estafilocócicas , Humanos , Pie Diabético/complicaciones , Estudios Retrospectivos , Prevalencia , Pacientes Ambulatorios , Infecciones Estafilocócicas/epidemiología , Infecciones Estafilocócicas/complicaciones , Infecciones Estafilocócicas/tratamiento farmacológico , Antibacterianos/uso terapéutico , Diabetes Mellitus/tratamiento farmacológicoRESUMEN
AIM: This study aims to explore the feasibility of using serial MRI without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot, in order to decide whether a large-scale trial is warranted. METHODS: A multicentre, randomised, prospective, two arm, open, feasibility study (CADOM) of people with diabetes with a suspected or confirmed diagnosis of Charcot neuroarthropathy. Participants were randomised (1:1) to 'standard care plus', including repeated foot temperature measurements and X-rays, or the intervention arm, with additional three-monthly MRI, until remission of Charcot neuroarthropathy or a maximum 12 months (active phase). Participants were then followed-up for a further 6 months, post remission to monitor for relapse of the Charcot neuroarthropathy (follow-up phase). Feasibility outcomes were recruitment, retention, data completeness, adherence to study procedures and safety of the intervention MRI. We also collected clinical efficacy outcomes, this included time in cast/off-loading device which will be the primary outcome of a future definitive trial. Finally, we collected patient reported outcomes, and data on health and social care usage. RESULTS: One-hundred and five people were assessed for eligibility at five sites. 64/105 potential participants meet the eligibility criteria to participate in the study. Forty-three participants were randomised: 20 to standard care plus and 23 to MRI intervention. The main reason for ineligibility was a previous episode of Charcot neuroarthropathy. Thirteen participants were withdrawn post-randomisation due to an alternative diagnosis being made. Of the remaining 30 participants, 19 achieved remission, 6 had not gone into remission at the end of the 12 month active phase so exited the study. Five participants were lost to follow-up. Of the MRIs that were not disrupted by COVID-19 pandemic 26/31 (84%) were completed. For the visits that were conducted face-to-face, completion rates of patient-reported outcome measures were between 71 and 100%. There were no safety incidents associated with the intervention MRI. As this was a feasibility study it was not designed to test the effectiveness of serial MRI in diagnosing remission. The time in cast/off-loading device was 235 (±108.3) days for the standard care plus arm compared to 292 (±177.4) days for the intervention arm. There was no statistical difference in the time in cast/off-loading device between the two arms of the study: Hazard Ratio (HR) 0.405 (95% CI 0.140-1.172), p = 0.096. DISCUSSION: The findings support a definitive randomised controlled trial to evaluate the effectiveness of MRI in diagnosing remission in Charcot neuroarthropathy. The rates of recruitment, retention, data, and MRI completeness show that a definitive study is feasible. STUDY REGISTRATION: ISRCTN, 74101606 . Registered on 6 November 2017.
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COVID-19 , Diabetes Mellitus , Humanos , Estudios de Factibilidad , Pandemias , Estudios Prospectivos , Imagen por Resonancia MagnéticaRESUMEN
AIMS: Charcot neuroarthropathy (CN) is a complication of neuropathy, in people with diabetes. Treatment requires the prolonged wearing of an offloading device, which can be challenging. The importance of understanding people's perspectives for promoting their engagement in self management is well known. However, no such studies have been done in CN. This qualitative study aimed to understand people's experiences of CN. METHODS: Semi-structured interviews with a purposive sample of 14 participants with CN, recruited from a randomised controlled trial. We gathered opinions, thoughts and the meanings participants attributed to their experiences of CN and its physical, socio-economic and physiological effects and how this affected their families and relationships. We analysed the interviews using Inductive Thematic Analysis. RESULTS: Four analytic themes were identified: (1) 'Trapped at home isolated and missing social life and daily life routines'; (2) 'Disruption to people's roles, responsibilities, relationships and mobility, which people adapted to try and address and manage'; (3) 'Pain which participants related to the direct or indirect consequences of wearing the cast or boot'; and (4) 'Blame for developing CN, attributed to themselves and healthcare professionals'. Participants described guilt about needing more support, expressing frustration, low mood and low self-esteem. CONCLUSION: This study highlights experiential aspects of the previously unrecognised burden of CN. Its physical, social and emotional impacts on participants and their families are substantial and sustained. There is a need to raise clinical awareness of CN and its wider effects. TRIAL REGISTRATION: ISRCTN74101606. Registered on 6 November 2017, http://www.isrctn.com/ISRCTN74101606?q=CADom&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search.
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Depresión , Diabetes Mellitus , Personal de Salud , Humanos , Dolor , Investigación CualitativaRESUMEN
BACKGROUND: Charcot neuroarthropathy is a complication of peripheral neuropathy associated with diabetes which most frequently affects the lower limb. It can cause fractures and dislocations within the foot, which may progress to deformity and ulceration. Recommended treatment is immobilisation and offloading, with a below knee non-removable cast or boot. Duration of treatment varies from six months to more than 1 year. Small observational studies suggest that repeated assessment with magnetic resonance imaging improves decision-making about when to stop treatment, but this has not been tested in clinical trials. This study aims to explore the feasibility of using serial magnetic resonance imaging without contrast in the monitoring of Charcot neuroarthropathy to reduce duration of immobilisation of the foot. A nested qualitative study aims to explore participants' lived experience of Charcot neuroarthropathy and of taking part in the feasibility study. METHODS: We will undertake a two-arm, open study and randomise 60 people with a suspected or confirmed diagnosis of Charcot neuroarthropathy from five NHS, secondary care multidisciplinary Diabetic Foot Clinics across England. Participants will be randomised 1:1 to receive magnetic resonance imaging at baseline and remission up to 12 months, with repeated foot temperature measurements and X-rays (standard care plus), or standard care plus with additional three-monthly magnetic resonance imaging until remission up to 12 months (intervention). Time to confirmed remission of Charcot neuroarthropathy with off-loading treatment (days) and its variance will be used to inform sample size in a full-scale trial. We will look for opportunities to improve the protocols for monitoring techniques and the clinical, patient-centred and health economic measures used in a future study. For the nested qualitative study, we will invite a purposive sample of 10-14 people able to offer maximally varying experiences from the feasibility study to take part in semi-structured interviews to be analysed using thematic analysis. DISCUSSION: The study will inform the decision whether to proceed to a full-scale trial. It will also allow deeper understanding of the lived experience of Charcot neuroarthropathy, and factors that contribute to engagement in management and contribute to the development of more effective patient-centred strategies. TRIAL REGISTRATION: ISRCTN, ISRCTN74101606. Registered on 6 November 2017.
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AIM: The management of acute Charcot neuroarthropathy relies on off-loading which is costly and time-consuming. Published studies have used monitoring techniques with unknown diagnostic precision to detect remission. We performed a systematic review of techniques for monitoring response to offloading in acute Charcot neuroarthropathy. MATERIALS AND METHODS: We included studies of off-loading which evaluated or described monitoring techniques in acute Charcot neuroarthropathy. PubMed, EMBASE, CINAHL and Cochrane databases were searched (January1993-July 2018). We extracted data from papers including study design, setting, population, monitoring techniques and treatment outcomes. We also extracted information on the cost, clinical applicability, sensitivity and specificity, safety and participant acceptability of the monitoring techniques. RESULTS: We screened 1205 titles, 140 abstracts and 45 full-texts, and included 29 studies. All studies were of low quality and at high risk of bias. In seven studies, the primary aim was to evaluate monitoring techniques: three evaluated magnetic resonance imaging, two thermography monitoring, one three-phase bone scanning and one Doppler spectrum analysis. The remaining 22 observational studies reported treatment outcomes and described the monitoring techniques used to assess the Charcot neuroarthropathy. Heterogeneity prevented the pooling of data. Very few studies included data on cost, clinical applicability, sensitivity and specificity, safety and patient acceptability of the monitoring techniques used. CONCLUSION: Multiple techniques have been used to evaluate remission in acute Charcot neuroathropathy but uncertainty remains about their effectiveness. We recommend further research into the influences of different monitoring techniques on treatment outcomes.
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BACKGROUND: Offloading interventions are commonly used in clinical practice to heal foot ulcers. The aim of this updated systematic review is to investigate the effectiveness of offloading interventions to heal diabetic foot ulcers. METHODS: We updated our previous systematic review search of PubMed, EMBASE, and Cochrane databases to also include original studies published between July 29, 2014 and August 13, 2018 relating to four offloading intervention categories in populations with diabetic foot ulcers: (a) offloading devices, (b) footwear, (c) other offloading techniques, and (d) surgical offloading techniques. Outcomes included ulcer healing, plantar pressure, ambulatory activity, adherence, adverse events, patient-reported measures, and cost-effectiveness. Included controlled studies were assessed for methodological quality and had key data extracted into evidence and risk of bias tables. Included non-controlled studies were summarised on a narrative basis. RESULTS: We identified 41 studies from our updated search for a total of 165 included studies. Six included studies were meta-analyses, 26 randomised controlled trials (RCTs), 13 other controlled studies, and 120 non-controlled studies. Five meta-analyses and 12 RCTs provided high-quality evidence for non-removable knee-high offloading devices being more effective than removable offloading devices and therapeutic footwear for healing plantar forefoot and midfoot ulcers. Total contact casts (TCCs) and non-removable knee-high walkers were shown to be equally effective. Moderate-quality evidence exists for removable knee-high and ankle-high offloading devices being equally effective in healing, but knee-high devices have a larger effect on reducing plantar pressure and ambulatory activity. Low-quality evidence exists for the use of felted foam and surgical offloading to promote healing of plantar forefoot and midfoot ulcers. Very limited evidence exists for the efficacy of any offloading intervention for healing plantar heel ulcers, non-plantar ulcers, and neuropathic ulcers with infection or ischemia. CONCLUSION: Strong evidence supports the use of non-removable knee-high offloading devices (either TCC or non-removable walker) as the first-choice offloading intervention for healing plantar neuropathic forefoot and midfoot ulcers. Removable offloading devices, either knee-high or ankle-high, are preferred as second choice over other offloading interventions. The evidence bases to support any other offloading intervention is still weak and more high-quality controlled studies are needed in these areas.
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Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 2/complicaciones , Pie Diabético/prevención & control , Medicina Basada en la Evidencia , Guías de Práctica Clínica como Asunto/normas , Pautas de la Práctica en Medicina/normas , Pie Diabético/etiología , Pie Diabético/rehabilitación , Manejo de la Enfermedad , Humanos , PronósticoRESUMEN
The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the use of offloading interventions to promote the healing of foot ulcers in people with diabetes and updates the previous IWGDF guideline. We followed the GRADE methodology to devise clinical questions and critically important outcomes in the PICO format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. For healing a neuropathic plantar forefoot or midfoot ulcer in a person with diabetes, we recommend that a nonremovable knee-high offloading device is the first choice of offloading treatment. A removable knee-high and removable ankle-high offloading device are to be considered as the second- and third-choice offloading treatment, respectively, if contraindications or patient intolerance to nonremovable offloading exist. Appropriately, fitting footwear combined with felted foam can be considered as the fourth-choice offloading treatment. If non-surgical offloading fails, we recommend to consider surgical offloading interventions for healing metatarsal head and digital ulcers. We have added new recommendations for the use of offloading treatment for healing ulcers that are complicated with infection or ischaemia and for healing plantar heel ulcers. Offloading is arguably the most important of multiple interventions needed to heal a neuropathic plantar foot ulcer in a person with diabetes. Following these recommendations will help health care professionals and teams provide better care for diabetic patients who have a foot ulcer and are at risk for infection, hospitalization, and amputation.
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Diabetes Mellitus Tipo 1/complicaciones , Diabetes Mellitus Tipo 2/complicaciones , Pie Diabético/prevención & control , Medicina Basada en la Evidencia , Guías de Práctica Clínica como Asunto/normas , Pautas de la Práctica en Medicina/normas , Pie Diabético/etiología , Pie Diabético/rehabilitación , Manejo de la Enfermedad , Humanos , Revisiones Sistemáticas como AsuntoRESUMEN
The hypothesis laid out in this thesis states that the early changes seen on an MR imaging in those with early Charcot neuroarthopathy may be due to mitochondrial dysfunction. In a Charcot foot, there is movement between bones. In an attempt to prevent this movement, the small muscles of the foot contract continuously when the foot is weight bearing. This contraction takes energy in the form of ATP. However, the reduction of glucose transport into the muscle cells due to insulin resistance / insufficiency, leads to reduction in the ATP producing capacity of the mitochondria. The ATP depletion affects the cell membrane gradient leading to mitochondrial and cellular swelling. These early cellular changes could then be picked up with MR imaging as muscle oedema.
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Pie Diabético/diagnóstico por imagen , Edema/diagnóstico por imagen , Enfermedades del Pie/diagnóstico por imagen , Imagen por Resonancia Magnética , Mitocondrias Musculares/patología , Modelos Biológicos , Adenosina Trifosfato/metabolismo , Permeabilidad de la Membrana Celular , Pie Diabético/metabolismo , Pie Diabético/patología , Edema/etiología , Retículo Endoplásmico/fisiología , Enfermedades del Pie/metabolismo , Enfermedades del Pie/patología , Humanos , Inmovilización , Resistencia a la Insulina , Mitocondrias Musculares/fisiología , Movimiento (Física) , Contracción Muscular , Soporte de PesoRESUMEN
INTRODUCTION: Piperacillin/tazobactam is a commonly used antibiotic for the empirical treatment of severe diabetic foot infections. One of the most feared complications of this drug is the development of pancytopenia. The aim of this study was to determine whether the use of piperacillin/tazobactam caused any hematological changes in patients admitted with severe diabetes-related foot infections from a specialist multidisciplinary foot clinic. Specifically, looking at whether it caused anemia, leukopenia, neutropenia, or thrombocytopenia. METHODS: A 1-year retrospective analysis of patients admitted to a tertiary care center for treatment of diabetes-related foot infection using piperacillin/tazobactam. Hematological indices, urea and electrolytes, and C-reactive protein (CRP) were recorded pretreatment, during treatment, and posttreatment. HbA1c, vitamin B12, folate, thyroid-stimulating hormone, and free thyroxin were also analyzed to exclude any potential confounders as a cause of pancytopenia. RESULTS: A total of 154 patients were admitted between 1 January 2016 and 31 December 2016 who received piperacillin/tazobactam for severe diabetes-related foot infection. On admission, white cell count and CRP were raised and fell significantly within the first 48 h. Other hematological factors did not change. Five patients developed a mild pancytopenia, of which three were unexplained. CONCLUSION: In this relatively small cohort, pancytopenia did not occur. As such, piperacillin/tazobactam appeared to have a low risk of adverse hematological outcomes and remains the treatment of choice for severe diabetes-related foot infections.
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AIMS: Glycaemic variability - the visit-to-visit variation in HbA1c - plays a possible role in the development of micro and macrovascular disease in patients with diabetes. Whether HbA1c variability is a factor determining wound healing in diabetic foot ulcers remains unknown. We aimed to determine whether HbA1c variability is associated with foot ulcer healing time. METHODS: A retrospective analysis of patients presenting to our specialist multidisciplinary foot clinic between July 2013 and March 2015, with at least three HbA1c measurements within five years of presentation and more than two follow-up reviews. HbA1c variation was measured by magnitude of standard deviation. RESULTS: 629 new referrals were seen between July 2013 and March 2015. Of these, 172 patients had their number of days to healing recorded and sufficient numbers of HbA1c values to determine variability. The overall geometric mean days to heal was 91.1 days (SD 80.8-102.7). In the low HbA1c variability group the geometric mean days to heal was 78.0 days (60.2-101.2) vs 126.9 days (102.0-158.0) in the high Hb1Ac variability group (pâ¯=â¯.032). Those with low HbA1c (<58 mmol/mol) and low variability healed faster than those with high HbA1c and high variability (73.5 days [59.5-90.8] vs 111.0 days [92.0-134.0], pâ¯=â¯.007). Additionally, our results show that time to healing is more dependent on the mean HbA1c than the variability in HbA1c (pâ¯=â¯.007). CONCLUSIONS/INTERPRETATION: Our data suggest that there was a significant association between HbA1c variability and healing time in diabetic foot ulcers.
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Pie Diabético/complicaciones , Úlcera del Pie/etiología , Glucosa/metabolismo , Hemoglobina Glucada/metabolismo , Cicatrización de Heridas/fisiología , Anciano , Instituciones de Atención Ambulatoria , Pie Diabético/sangre , Femenino , Humanos , Masculino , Estudios RetrospectivosRESUMEN
The optimal way to manage diabetic foot osteomyelitis remains uncertain, with debate in the literature as to whether it should be managed conservatively (ie, nonsurgically) or surgically. We aimed to identify clinical variables that influence outcomes of nonsurgical management in diabetic foot osteomyelitis. We conducted a retrospective study of consecutive patients with diabetes presenting to a tertiary center between 2007 and 2011 with foot osteomyelitis initially treated with nonsurgical management. Remission was defined as wound healing with no clinical or radiological signs of osteomyelitis at the initial or contiguous sites 12 months after clinical and/or radiological resolution. Nine demographic and clinical variables including osteomyelitis site and presence of foot pulses were analyzed. We identified 100 cases, of which 85 fulfilled the criteria for analysis. After a 12-month follow-up period, 54 (63.5%) had achieved remission with nonsurgical management alone with a median (interquartile range) duration of antibiotic treatment of 10.8 (10.1) weeks. Of these, 14 (26%) were admitted for intravenous antibiotics. The absence of pedal pulses in the affected foot (n = 34) was associated with a significantly longer duration of antibiotic therapy to achieve remission, 8.7 (7.1) versus 15.9 (13.3) weeks (P = .003). Osteomyelitis affecting the metatarsal was more likely to be amputated than other sites of the foot (P = .016). In line with previous data, we have shown that almost two thirds of patients presenting with osteomyelitis healed without undergoing surgical bone resection.
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Tratamiento Conservador , Pie Diabético/terapia , Osteomielitis/terapia , Anciano , Pie Diabético/complicaciones , Humanos , Persona de Mediana Edad , Osteomielitis/complicaciones , Pronóstico , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
INTRODUCTION: The optimal management for patients with diabetes and peripheral vascular disease-intermittent claudication or critical limb ischemia (CLI)-remains undetermined. METHODS: In a single-center retrospective analysis, we compared 1- and 5-year amputation-free survival rates in patients undergoing angiography subsequently treated with medical therapy or revascularization. RESULTS: 78 patients were included, 56 with CLI (mean age 77 years); 22 with claudication (mean age 75 years). Of the CLI cohort, 30 patients were medically treated. Their 1-year amputation-free survival rate was similar to those treated with revascularization (46.7% versus 50.0%, respectively). 8 patients in the claudicant cohort were treated conservatively. The 1-year amputation-free survival rate was 75.0% for conservative treatment versus 78.6% in those revascularized. Within the CLI cohort, in those conservatively treated 20% underwent major, and 16.7% minor amputations, compared to 15.4% and 23.1% in those revascularized. At 5 years in the claudicant cohort, the amputation-free survival rate was 37.5% with medical treatment, versus 71.4% for those treated with revascularization. For CLI, the 5-year amputation-free survival rate was 10% for conservative treatment, versus 26.9% for revascularization. CONCLUSION: We found similar rates of amputation at 1 year for patients treated medically or revascularized. However, at 5 years, the amputation-free survival rate was markedly higher in revascularized patients compared to those medically managed. Our study highlights the potential role of predicting life expectancy when considering treatment, with the option of surgical treatment offered to those in whom survival is predicted to be longer than 5 years. However, larger studies with matched cohorts are now needed to confirm these findings.
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Medication to aid weight loss and weight loss surgery are becoming more commonly available for people with diabetes. As a result of profound weight loss, diabetes may go into remission and many biochemical and physical parameters improve. However, some of the end organ damage associated with diabetes may not improve, peripheral neuropathy being an example. We present three cases in people with diabetes and pre-existing peripheral neuropathy who had lost significant weight. They became more mobile and developed a Charcot foot despite their diabetes improving significantly. People who have lost significant weight should continue to monitor their feet because the risks of foot disease remain even if diabetes goes into remission.