Clinical trial NCT01370837: Neurogenic Inflammation in Diabetes
Official title: Neurogenic Inflammation in Diabetic Polyneuropathy and Charcot Neuro-osteoarthropathy: Response to Intracutaneous Candida Albicans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Polyneuropathies
Arthropathy, Neurogenic
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Diabetes Research Foundation
First posted: 2011-06-10
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Induration Size as a Response to Intracutaneous Candida Albicans.
timeFrame: 48 hours after injection.
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Nicolaas Schaper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pickwell K, Geerts M, van Moorsel D, Hilkman D, Kars M, Schaper NC. Regional differences in cell-mediated immunity in people with diabetic peripheral neuropathy. Diabet Med. 2020 Feb;37(2):350-355. doi: 10.1111/dme.14143. Epub 2019 Oct 10.