Neurogenic Inflammation in Diabetes

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370837
• Other study ID #: METC 11-2-044
• Status: Completed
• Phase: N/A
• First received: June 7, 2011
• Last updated: April 16, 2015
• Start date: May 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

• Gout.

• 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthropathy, Neurogenic
• Diabetes Mellitus
• Neurogenic Inflammation
• Polyneuropathies

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Dutch Diabetes Research Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induration Size as a Response to Intracutaneous Candida Albicans.		48 hours after injection.	No