Diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
This study is a 2-arm open labelled randomised controlled study. It investigates the feasibility of using serial MRI to monitor CN. The study lasts for 3 years. There is an 18-month recruitment period
Sponsors
Norfolk and Norwich University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes are assessed using eCRF reported by research teams from patient notes: 1. The proportion of patients who meet the eligibility criteria 2. The number of eligible patients recruited 3. The number of participants in which an alternative diagnosis is made during the active phase of the trial 4. The proportion of patients that withdraw or are lost to follow up 5. Statistical parameters of the key outcome measures to inform a sample size calculation for a definitive trial (estimate of effect size) 6. Ability to collect quality of life and resource use data | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy outcome measures are assessed using the eCRF reported by research teams from patient notes: 1.1. Preliminary data on days with immobilisation at the end of the active phase of the study 1.2. Progression of foot deformity from randomisation to the end of the follow up phase of the study 1.3. Number of new ulcerations on the index foot at the end of the follow up phase of the study 1.4. Number of new ulcerations on the contralateral foot at the end of the follow up phase of the study 1.5. Number of new infections on the index foot at the end of the follow up phase of the study 1.6. Number of new infections on the contralateral foot at the end of the follow up phase of the study 1.7. Number and severity of falls (Hopkins Fall Grading System) at the end of the follow up phase of the study 1.8. Number of minor and major amputations on the index foot at the end of the follow up phase of the study 1.9. Number of minor and major amputations on the contralateral foot at the end of the follow up phase of the study 1.10. The number of participants in each arm requiring further intervention for CN (e.g. further immobilisation) within 6 months of remission Patient Reported Outcome Measures are measured at 3, 6, 9, 12 months, at remission and at the end of the follow up phase of the study: 2.1. Level of pain is measured using the Numeric Pain Rating Scale - VAS 2.2. Health related quality of life is measured using EQ-5D-5L and SF12 2.3. Anxiety and depression is measured using the Hospital Anxiety and Depression Scale (HADS) Economic Evaluation 3.1. Resource use is assessed through a patient diary at the end of the follow up phase of the study | — |
Countries
England, United Kingdom
Outcome results
None listed