临床试验/ISRCTN74101606

ISRCTN74101606已完成未知

A randomised feasibility trial to define outcome measures for acute Charcot neuroarthropathy in Diabetes and their use in assessing clinical management

orfolk and Norwich University Hospitals NHS Foundation Trust0 个研究点目标入组 43 人开始时间: 2017年11月10日最近更新: 2023年2月6日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方: orfolk and Norwich University Hospitals NHS Foundation Trust
入组人数: 43

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32549996/ protocol (added 19/06/2020) Other publications in https://pubmed.ncbi.nlm.nih.gov/34985149/ Qualitative study results (added 29/11/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36703174/ (added 27/01/2023)

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Participants who are willing and have capacity to give informed consent.
•2. People with diabetes as diagnosed by the WHO criteria https://www.diabetes.org.uk/Documents/Professionals/hba1c_diagnosis.1111.pdf (Appendix 1)
•3. Age 18 years or over
•4. New or suspected new diagnosis of acute CN (no previous incidence of acute CN within the last 6 months on the same foot) treated with off-loading
•5. Understand written and verbal instructions in English

排除标准

•1. People who have received a transplant and others receiving immunosuppressant therapy or using glucocorticoids other than in the routine management of glucocorticoid deficiency
•2. Contra-indication for MRI
•3. Treatment for previous suspected CN on the same foot in the last 6 months
•4. Suspected or confirmed bilateral active CN at presentation
•5. Active osteomyelitis at randomisation
•6. Previous contralateral major amputation
•7. Inability to have an MRI scan
•8. Patients receiving palliative care

研究者

发起方

orfolk and Norwich University Hospitals NHS Foundation Trust

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