Neurogenic Inflammation in Diabetes

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.

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Key information

Conditions

Diabetes Mellitus Arthropathy, Neurogenic Endocrine System Diseases Glucose Metabolism Disorders Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intracutaneous injection of Candida albicans antigen.

Other

Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.

Other

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.

Primary outcomes

Induration Size as a Response to Intracutaneous Candida Albicans.

Time frame: 48 hours after injection.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

Dutch Diabetes Research Foundation

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jun 10, 2011
Registry last updated: May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed