Neurogenic Inflammation in Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Polyneuropathies; Arthropathy, Neurogenic
• Interventions: Other: Intracutaneous injection of Candida albicans antigen.; Other: Temperature measurement.

• Registration Number: NCT01370837
• Lead Sponsor: Maastricht University Medical Center

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 Description

Not available

Study Timeline

• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Study Start: 2012-05
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2015-03-30
• Results First Submitted QC: 2015-03-30
• Status Verified: 2015-04
• Results First Posted: 2015-04-10
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	Intracutaneous injection of Candida albicans antigen.	-
Diabetes	Intracutaneous injection of Candida albicans antigen.	Patients with diabetes mellitus without polyneuropathy.
Polyneuropathy	Intracutaneous injection of Candida albicans antigen.	Patients with diabetes and polyneuropathy.
Healthy controls	Temperature measurement.	-
Polyneuropathy	Temperature measurement.	Patients with diabetes and polyneuropathy.
Diabetes	Temperature measurement.	Patients with diabetes mellitus without polyneuropathy.

Primary Outcome Measures

Name	Time	Method
Induration Size as a Response to Intracutaneous Candida Albicans.	48 hours after injection.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands