A randomised feasibility study to assess the use of serial magnetic resonance imaging to reduce treatment times in Charcot neuroarthropathy in people with diabetes

Not Applicable

Completed

• Conditions: Diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN74101606
• Lead Sponsor: orfolk and Norwich University Hospitals NHS Foundation Trust

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-10
• Study Completion: 2021-05-31
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified