Neurogenic Inflammation in Diabetic Polyneuropathy and Charcot Neuro-osteoarthropathy: Response to Intracutaneous Candida Albicans
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Induration Size as a Response to Intracutaneous Candida Albicans.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Kristy Pickwell
MD
Maastricht University Medical Center
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Induration Size as a Response to Intracutaneous Candida Albicans.
Time Frame: 48 hours after injection.