NCT01370837

Neurogenic Inflammation in Diabetes

Neurogenic Inflammation in Diabetic Polyneuropathy and Charcot Neuro-osteoarthropathy: Response to Intracutaneous Candida Albicans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus
• Polyneuropathies
• Arthropathy, Neurogenic

Interventions

Type	Name	Description
OTHER	Intracutaneous injection of Candida albicans antigen.	Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
OTHER	Temperature measurement.	Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2011-06-10
• Last updated: 2015-05-06
• Results posted: 2015-04-10

Locations

1 site across 1 country: Netherlands