Defining Outcome Measures for Acute Charcot Neuroarthropathy in Diabetes and Their Use in Assessing Clinical Management

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to explore the use of serial magnetic resonance imaging (MRI) in an attempt to reduce the duration of immobilisation of the foot and thereby reduce the morbidity associated with its routine management and reduce costs. The project will have two components: a feasibility study and embedded within this a qualitative study of the patient's perspective of the experience of being diagnosed with Charcot neuroarthropathy (CN) and undergoing treatment.

Detailed Description
-----------------
The aim of the study is to assess the feasibility of using serial magnetic resonance imaging (MRI) to reduce treatment times in Charcot in people with diabetes. Charcot is a devastating complication for people who develop it. There are over 4000 new cases of Charcot diagnosed every year. If the inflammation goes on for long enough it can cause fractures and dislocations within the foot, which left untreated can lead to foot deformity and complications such as ulcerations. A diagnosis of Charcot has been shown to reduce people's quality of life. People who have had this condition die on average 14years younger than the general population. Every year about 50-100 people who have been diagnosed with Charcot neuroarthropathy undergo an amputation of their leg. Charcot is treated by wearing a non-removable cast or boot. No-one knows how long this treatment should last, some recommend 6 months, others more than a year. Early treatment has been shown to lead to fewer complications. There is some information from small studies that repeated assessment with MRI may prove useful in helping clinicians decide when to stop treatment, and it may decrease treatment times. This study will be a feasibility study involving 60 people. Patients will be recruited from hospital run Diabetic Foot Clinics. Patients will be randomised to either receive MRI at baseline 3,6,9 and 12 months or to receive current usual care; repeated foot temperature measurements and x-rays. If the study results indicate the study is feasible to do, the information will be used to design a much larger study. Some patients will also be asked to participate in an interview at the end of the study, to gain insights into their experience of having Charcot and involvement in the study.

Official Title
-----------------
A Randomised Feasibility Trial to Define Outcome Measures for Acute Charcot Neuroarthropathy in Diabetes and Their Use in Assessing Clinical Management (CADOM)

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Radiation: Serial MRIs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants who are willing and have capacity to give informed consent People with diabetes as diagnosed by the WHO criteria Age 18 years or over New or suspected diagnosis of acute CN (no previous incidence of acute CN within the last 6 months on the same foot) treated with off-loading Understand written and verbal instructions in English Exclusion Criteria: People who have received a transplant and others receiving immunosuppressant therapy or using long term oral glucocorticoids other than in the routine management of glucocorticoid deficiency. Participants on a low doses of oral glucocorticoids (<10mgs for ≤7 days) are eligible to participate in the study. Participation in another intervention study on active CN Contra-indication for MRI Treatment for previous suspected CN on the same foot in the last 6 months Suspected or confirmed bilateral active CN at presentation Active osteomyelitis at randomisation Previous contralateral major amputation Inability to have an MRI scan Patients receiving palliative care

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention: Serial use of MRI at 3, 6, 9 and 12 months to identify disease resolution and thus discontinue immobilisation in addition to standard care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (Intervention - Standard Care and Serial MRIs)<br>Immobilisation discontinued on the basis of MRI defined disease resolution at 3, 6, 9 or 12 months. In the intervention arm participants will receive additional MRIs at 3, 6, 9 and 12 months. Patients randomised to serial MRI will not undergo further MRI once remission has been diagnosed i.e. if remission is diagnosed at 6 months the MRI at 9 and 12 months will not occur. | Radiation: Serial MRIs<br>* Serial use of MRI at 3, 6, 9 and 12 months to identify disease resolution and thus discontinuation of immobilisation plus standard care.<br>* Other names: Serial use of MRI at 3, 6, 9 and 12 months;|
| No Intervention: Arm B (Control - Standard Care and one additional MRI)<br>Immobilisation discontinued on the basis of clinical remission determined by skin temperature measurement and MRI. In the standard care arm participants will receive one additional MRI when the temperature measurements, X-ray and/or signs and symptoms indicate to the clinical team that the foot is in remission. A temperature difference of ≤ 2ºC which is maintained or improves on two separate consecutive occasions for a period of ≥4weeks will be the indicator to arrange the second MRI, to confirm the diagnosis of remission. If participants in either arm of the trial have not reached remission at the end of the 12 month active phase of the study they will exit the study. Ongoing standard care will be provided by their clinical team. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who meet eligibility criteria. | Feasibility outcome. | through study completion, an average of 4 years | 
| The number of eligible patients recruited. | Feasibility outcome. | through study completion, an average of 4 years | 
| The number of participants in which an alternative diagnosis of the foot disease is made during the intervention phase of the trial. | Feasibility outcome. | through study completion, an average of 4 years | 
| The proportion of patients that withdraw or are lost to follow up. | Feasibility outcome. The term 'withdrawal' encompasses two potential scenarios; withdrawal due to loss of consent or withdrawal due to death. | through study completion, an average of 4 years | 
| Quality of life and resource data collection - Sf12. | Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using Sf12. | through study completion, an average of 4 years | 
| Quality of life and resource data collection - EQ5D. | Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using EQ5D. | through study completion, an average of 4 years | 
| Quality of life and resource data collection - HADS. | Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using HADS. | through study completion, an average of 4 years | 
| Quality of life and resource data collection - VAS. | Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using VAS. | through study completion, an average of 4 years | 
| Quality of life and resource data collection - patient diary. | Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using patient diary. | through study completion, an average of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days with immobilisation | Days with immobilisation measured at the end study. | through study completion, an average of 4 years | 
| Progression of foot deformity as documented by measuring radiological foot alignment angles. | All x-rays will be taken in a weight bearing position with standard views as per WPD. Comparison from baseline, diagnosis of remission, and six months after remission. | Six months after remission. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Charcot neuroarthropathy