Factors Associated With Quality of Life Outcomes in Diabetic Patients With Chronic Wound-free Charcot Foot
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 17
- 主要终点
- Results of the SF36 questionnaire at inclusion
研究概览
简要总结
Charcot foot, characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot, is a complication of diabetes that is still poorly understood by patients and caregivers. The clinical signs are non-specific and it is therefore largely underestimated due to a delay in diagnosis/lack of diagnosis.This study will be on a prospective multicenter cohort of patients with chronic Charcot's foot in France to evaluate the evolution of quality of life at 2 years, as well as predictive factors in order to better identify subjects with the worst outcome among this population.
Our hypothesis is that, in patients with chronic Charcot foot, the deterioration in quality of life over time is primarily related to loss of foot and ankle functionality, foot and ankle deformity and the presence of foot wounds/comorbidities/severe diabetic complications.
详细描述
Diabetes mellitus is a chronic disease, representing a major public health problem. An estimated 537 million people have diabetes. Charcot foot, also known as neurogenic osteoarthropathy (NAO), is one of the complications of diabetes secondary to diabetic neuropathy. It is characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot. Charcot foot is a complication of diabetes that is still poorly understood by patients and caregivers, with non-specific clinical signs. It is therefore largely underestimated, since it is estimated that there is a delay in diagnosis or a lack of diagnosis in approximately 25% of cases.
The objective of our study is to conduct a prospective multicenter cohort of patients with chronic Charcot's foot in France in order to evaluate the evolution of the quality of life at 2 years, as well as its predictive factors. In this way, we will be better able to identify the subjects with the worst outcome among the chronic Charcot foot population.
Our hypothesis is that the deterioration in quality of life over time in patients with chronic Charcot foot is primarily related to loss of foot and ankle functionality, foot and ankle deformity, the presence of foot wounds and/or comorbidities or severe diabetic complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •patients with Type 1 or 2 diabetes or secondary diabetes
- •patient hospitalized or consulting for osteoarthropathy in its chronic stage, without wounds
- •patients affiliated to or beneficiaries of a health insurance scheme.
- •adult patients (≥18 years old).
排除标准
- •patients with non-diabetic osteoarthropathy of the nerves.
- •patients with acute diabetic osteoarthropathy of the nerves.
- •patients with a foot ulcer
- •patients who have expressed opposition to participating in the study.
- •patients in an exclusion period determined by another study.
- •patients under court protection, guardianship or trusteeship.
- •patients for whom it is impossible to give informed information.
- •pregnant, parturient, or breastfeeding patients.
结局指标
主要结局
Results of the SF36 questionnaire at inclusion
时间窗: Day 0
The SF-36 questionnaire is a quality of life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.
Results of the SF36 questionnaire at Month 12
时间窗: Month 12
The SF-36 questionnaire is a quality of life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.
Results of the SF36 questionnaire at Month 24
时间窗: Month 24
The SF-36 questionnaire is a quality of life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.
Results of the FAAM-F questionnaire at inclusion
时间窗: Day 0
The FAAM is a self-administered questionnaire that measures physical function of the foot and ankle. It is adapted and validated in the evaluation of diabetic foot disease. It consists of an assessment of activity of daily living and a sports assessment. The FAAM has been translated and validated in French. Score from 0 to 100.
Results of the FAAM-F questionnaire at Month 12
时间窗: Month 12
The FAAM is a self-administered questionnaire that measures physical function of the foot and ankle. It is adapted and validated in the evaluation of diabetic foot disease. It consists of an assessment of activity of daily living and a sports assessment. The FAAM has been translated and validated in French. Score from 0 to 100.
Results of the FAAM-F questionnaire at Month 24
时间窗: Month 24
The FAAM is a self-administered questionnaire that measures physical function of the foot and ankle. It is adapted and validated in the evaluation of diabetic foot disease. It consists of an assessment of activity of daily living and a sports assessment. The FAAM has been translated and validated in French. Score from 0 to 100.
次要结局
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Retinopathy(Month 12)
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Peripheral vegetative neuropathy.(Month 24)
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Heart failure(Month 24)
- A. Evolution of X-ray measurements of bone and joint deformity of the foot. Lisfranc metatarsal misalignment (Méary's Line)(Month 24)
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot: Méary's angle.(Month 24)
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Calcaneal slope(Month 24)
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Djian Annonier angle(Month 24)
- A. Evolution of the radiologic measurements of bone and joint deformity of the foot. Rearfoot alignment(Month 24)
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Lower extremity arteriopathy(Month 24)
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. History of strokes(Month 24)
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Smoking(Month 24)
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Alcohol status(Month 24)
- C. Medical and/or surgical treatment for Charcot foot.(Month 24)
- D. Incidence of hospitalization(Month 24)
- F. Presence of an amputation at inclusion(Day 0)
- I. Depression according to the PHQ-2 self-questionnaire(Month 12)
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Nephropathy.(Month 24)
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Charlson Comorbidity Index(Month 24)
- E. Presence of a wound/wounds(Month 24)
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Supra-aortic trunk involvement(Month 24)
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Coronary artery disease(Month 24)
- B. Estimated prevalence of complications of diabetes and comorbidities at inclusion. Arterial hypertension(Month 24)
- E. Presence of an infection(Month 24)
- G. Estimated incidence of amputations(Month 12)
- K. Sanders Classification of the Charcot Foot(Month 12)
- G. Presence of an amputation(Month 24)
- H. Precarity of patients with chronic Charcot foot.(Month 24)
- I. Depression according to the PHQ-9 self-questionnaire(Month 24)
- J. Mortality rate(Month 24)