ISRCTN74101606
Completed
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 sites43 target enrollmentNovember 10, 2017
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- orfolk and Norwich University Hospitals NHS Foundation Trust
- Enrollment
- 43
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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