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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.

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.

Abstract 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.

Abstract 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.