A Randomised Feasibility Trial to Define Outcome Measures for Acute Charcot Neuroarthropathy in Diabetes and Their Use in Assessing Clinical Management (CADOM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The proportion of patients who meet eligibility criteria.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
It is not possible to blind this study due to the nature of reporting the MRIs, whereby comparison is made with the previous images, which indicates the trial arm the participant has been randomised to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The proportion of patients who meet eligibility criteria.
时间窗: through study completion, an average of 4 years
Feasibility outcome.
The number of eligible patients recruited.
时间窗: through study completion, an average of 4 years
Feasibility outcome.
The number of participants in which an alternative diagnosis of the foot disease is made during the intervention phase of the trial.
时间窗: through study completion, an average of 4 years
Feasibility outcome.
The proportion of patients that withdraw or are lost to follow up.
时间窗: through study completion, an average of 4 years
Feasibility outcome. The term 'withdrawal' encompasses two potential scenarios; withdrawal due to loss of consent or withdrawal due to death.
Quality of life and resource data collection - Sf12.
时间窗: through study completion, an average of 4 years
Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using Sf12.
Quality of life and resource data collection - EQ5D.
时间窗: through study completion, an average of 4 years
Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using EQ5D.
Quality of life and resource data collection - HADS.
时间窗: through study completion, an average of 4 years
Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using HADS.
Quality of life and resource data collection - VAS.
时间窗: through study completion, an average of 4 years
Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using VAS.
Quality of life and resource data collection - patient diary.
时间窗: through study completion, an average of 4 years
Feasibility outcome. Feasibility of quality of life and resource data collection will be assessed for data completeness and consistency using patient diary.
次要结局
- Days with immobilisation(through study completion, an average of 4 years)
- Progression of foot deformity as documented by measuring radiological foot alignment angles.(Six months after remission.)