NCT05104944

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
RADIATION	Serial MRIs	Serial use of MRI at 3, 6, 9 and 12 months to identify disease resolution and thus discontinuation of immobilisation plus standard care.

Timeline

• Start date: 2017-11-20
• Primary completion: 2019-11-30
• Completion: 2021-05-04
• First posted: 2021-11-03
• Last updated: 2021-11-03

Locations

1 site across 1 country: United Kingdom