Neurogenic Inflammation in Diabetes

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Polyneuropathies; Diabetes Mellitus; Arthropathy, Neurogenic

Treatments: Other: Intracutaneous injection of Candida albicans antigen.; Other: Temperature measurement.

Study type: Interventional

Funder types: Other

Identifiers

NCT01370837

METC 11-2-044

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

Healthy controls

Experimental group

Treatment:

Other: Intracutaneous injection of Candida albicans antigen.

Other: Temperature measurement.

Diabetes

Experimental group

Description:

Patients with diabetes mellitus without polyneuropathy.

Treatment:

Other: Intracutaneous injection of Candida albicans antigen.

Other: Temperature measurement.

Polyneuropathy

Experimental group

Description:

Patients with diabetes and polyneuropathy.

Treatment:

Other: Intracutaneous injection of Candida albicans antigen.

Other: Temperature measurement.