Clinical trial NCT05104944: Defining Outcome Measures for Acute Charcot Neuroarthropathy in Diabetes and Their Use in Assessing Clinical Management
Official title: A Randomised Feasibility Trial to Define Outcome Measures for Acute Charcot Neuroarthropathy in Diabetes and Their Use in Assessing Clinical Management (CADOM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Charcot neuroarthropathy
Lead sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of East Anglia
First posted: 2021-11-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The proportion of patients who meet eligibility criteria.
timeFrame: through study completion, an average of 4 years
measure: The number of eligible patients recruited.
timeFrame: through study completion, an average of 4 years
measure: The number of participants in which an alternative diagnosis of the foot disease is made during the intervention phase of the trial.
timeFrame: through study completion, an average of 4 years
measure: The proportion of patients that withdraw or are lost to follow up.
timeFrame: through study completion, an average of 4 years
measure: Quality of life and resource data collection - Sf12.
timeFrame: through study completion, an average of 4 years
measure: Quality of life and resource data collection - EQ5D.
timeFrame: through study completion, an average of 4 years
measure: Quality of life and resource data collection - HADS.
timeFrame: through study completion, an average of 4 years
measure: Quality of life and resource data collection - VAS.
timeFrame: through study completion, an average of 4 years
measure: Quality of life and resource data collection - patient diary.
timeFrame: through study completion, an average of 4 years
Secondary outcomes:
measure: Days with immobilisation
timeFrame: through study completion, an average of 4 years
measure: Progression of foot deformity as documented by measuring radiological foot alignment angles.
timeFrame: Six months after remission.
Other outcomes:
measure: Pain in the foot, ankle or leg measured, using the Numeric Pain Rating Scale.
timeFrame: At randomisation, and three monthly until patient is in remission. Also collected at 1 month and 6 months post remission
measure: Health related quality of life.
timeFrame: At randomisation, and three monthly until patient is in remission. Also collected at 1 month and 6 months post remission
measure: Psychological health status.
timeFrame: At randomisation, and three monthly until patient is in remission. Also collected at 1 month and 6 months post remission
measure: EQ-5D-5L
timeFrame: At randomisation, and three monthly until patient is in remission. Also collected at 1 month and 6 months post remission
measure: Economic Evaluation - Reported through a patient diary
timeFrame: At randomisation, and three monthly until patient is in remission. Also collected at 1 month and 6 months post remission
Locations:
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
state: Norfolk
Study officials:
affiliation: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
name: Catherine Gooday
role: STUDY_CHAIR
References: