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Clinical Trials/NCT01370837
NCT01370837
Completed
Not Applicable

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

Maastricht University Medical Center1 site in 1 country41 target enrollmentMay 2012

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.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
January 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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.

Study Sites (1)

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