CADOM
Research type
Research Study
Full title
A randomised feasibility trial to define outcome measures for acute Charcot neuroarthropathy in Diabetes and their use in assessing clinical management.
IRAS ID
222668
Contact name
Catherine Gooday
Contact email
Sponsor organisation
Norfolk & Norwich University NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Research Summary
The aim of the study is to assess the feasibility of using serial 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 of 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.
Results of Summary
Charcot is a serious consequence of diabetes which affects the foot. People have to wear a cast or boot for up to 12 months, and this can be hard to live with. It is difficult for clinicians to know how long to continue treatment. Some studies have shown that monitoring with Magnetic resonance imaging may be useful in deciding when to stop treatment.
In this research we:
• Completed a literature review to find out what was known about this topic.
• Completed a small study to assess the feasibility of conducting a large study on Magnetic resonance imaging in Charcot.
• Spoke to people to understand what it is like to live with Charcot.
The literature showed that clinicians use different ways to monitor Charcot. We do not know the benefits, risks, and costs of these different approaches. Treatment maybe being stopped early or carried on for longer than needed.
We found that participants are prepared to take part in a study on monitoring in Charcot. We also found that is it possible, and safe to complete regular Magnetic resonance imaging.
When we spoke to people, we found that Charcot has long lasting physical, social, emotional, and financial effects on them and their families. People report being frustrated, have low mood, and low self-esteem.
The recommendations are to:
• Conduct a large study to assess the effectiveness of regular Magnetic resonance imaging.
• Ensure that people have access to emotional, social care and voluntary organisations support.
If we can prove the Magnetic resonance imaging is a more effective way to monitor Charcot, then this could save the NHS money. People would regain their independence and go back to work sooner. If people are better supported to manage the emotional and physical consequences of Charcot, then this could improve people’s quality of life and wellbeing.REC name
East Midlands - Derby Research Ethics Committee
REC reference
17/EM/0288
Date of REC Opinion
4 Oct 2017
REC opinion
Further Information Favourable Opinion