Neurogenic Inflammation in Diabetic Polyneuropathy and Charcot Neuro-osteoarthropathy: Response to Intracutaneous Candida Albicans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Induration Size as a Response to Intracutaneous Candida Albicans.
研究概览
简要总结
Polyneuropathy is a complication of diabetes mellitus which leads to decreased sensation in arms and legs. This in turn can lead to the development of (infected) foot ulcers. Charcot's disease can also be a consequence of polyneuropathy. Patients with Charcot's disease suddenly develop a red, warm and swollen foot, like an infection. Charcot's disease leads to foot fractures. After these fractures have healed, the shape of the foot can be dramatically altered. This altered shape of the foot increases the risk of developing foot ulcers. Nerves are important in regulating the inflammatory response. This study aims to investigate whether the inflammatory response is different in patients with polyneuropathy with and without a history of Charcot's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with type 2 diabetes with and without polyneuropathy.
- •Patients with type 2 diabetes with a history of Charcot's disease.
- •Healthy controls.
- •Signed informed consent.
排除标准
- •Peripheral arterial disease: toe pressure < 70 mm Hg and/or transcutaneous oxygen tension < 40 mm Hg and/or claudication.
- •Renal insufficiency: MDRD creatinin clearance < 30 ml/min.
- •Systemic disease such as vasculitis or rheumatoid arthritis.
- •Malignancy.
- •(Diabetic) foot ulcer.
- •Bacterial infection of an extremity.
- •Skin condition of the dorsal aspect of the foot or the medial side of the upper arm.
- •Bleeding disorder such as hemophilia.
- •Use of medication for asthma.
- •Impaired immunity such as in HIV/AIDS.
- •Capillary blood glucose < 3 mmol/l or > 20 mmol/l at the time of the study.
- •Peripheral oedema.
- •Vaccination in the two months prior to study inclusion.
- •Chemotherapy or radiation therapy in the twelve months prior to study inclusion.
- •Surgery in the two months prior to study inclusion.
- •Previous adverse reaction to Candida albicans antigen.
- •Acute infection at the time of the study or in the month prior to study inclusion.
- •Transfusion in the two months prior to study inclusion.
- •Use of immunosuppressants in the two months prior to study inclusion.
- •Pregnancy or breastfeeding.
结局指标
主要结局
Induration Size as a Response to Intracutaneous Candida Albicans.
时间窗: 48 hours after injection.
次要结局
未报告次要终点
研究者
Kristy Pickwell
MD
Maastricht University Medical Center