eurogenic inflammation in diabetic polyneuropathy and Charcot neuro-osteoarthropathy: response to intracutaneous Candida albicans

Completed

Conditions: Charcot's disease.
Diabetic polyneuropathy
10012653
10005959
10034606

Registration Number: NL-OMON36125

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

Patients with type 2 diabetes with and without polyneuropathy aged 40-75 years. The presence of polyneuropathy is assessed by means of the Valk score and measurement of the conduction velocity in the n. suralis.
Patients with type 2 diabetes with a history of Charcot*s disease aged 40-75 years.
Healthy controls aged 40-75 years.
Signed informed consent.

Exclusion Criteria

Peripheral arterial disease.
Active Charcot's disease.
Renal insufficiency.
Systemic disease.
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.
Use of medication for asthma.
Impaired immunity.
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.
History of anaphylaxis.
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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In all groups extent of induration as a response to intracutaneous Candida<br /><br>albicans extract in four concentrations (1, 1:1,7, 1:5, 1:10) after 24, 48 and<br /><br>72 hours. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Temperature difference between injection site of different concentrations of<br /><br>Candida albicans on the foot and arm and the same location on the contralateral<br /><br>foot and arm.<br /><br>In 3 participants per group (with exception of the patients with a history of<br /><br>Charcot neuro-osteoarthropathy) characterization of the induration and the<br /><br>difference herein between the groups by skin biopsy.</p><br>