Clinical Trial: Neurogenic Inflammation in Diabetes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Maastricht University Medical Center

Current Primary Outcome: Induration Size as a Response to Intracutaneous Candida Albicans. [ Time Frame: 48 hours after injection. ]

Original Primary Outcome:

  • Induration size as a response to intracutaneous Candida albicans. [ Time Frame: 24 hours after injection. ]
  • Induration Size as a Response to Intracutaneous Candida Albicans. [ Time Frame: 48 hours after injection. ]
  • Induration size as a response to intracutaneous Candida albicans. [ Time Frame: 72 hours after injection. ]


Current Secondary Outcome:

Original Secondary Outcome:

  • Temperature at the injection site of the highest concentration of Candida albicans antigen on the foot, compared to the same location on the contralateral foot. [ Time Frame: 24, 48 and 72 hours after injection. ]
  • Nature of the induration that appears as a response to intracutaneous Candida albicans evaluated by microscopy of a skin biopsy taken at the injection site of the highest concentration of Candida albicans on the foot. [ Time Frame: 72 hours after injection. ]


Information By: Maastricht University Medical Center

Dates:
Date Received: June 7, 2011
Date Started: May 2012
Date Completion:
Last Updated: April 16, 2015
Last Verified: April 2015