N/A
N=41
Neurogenic Inflammation in Diabetes
Diabetes Mellitus · Polyneuropathies · Arthropathy, Neurogenic
Bottom Line
View on ClinicalTrials.gov: NCT01370837 ↗Enrolled (actual)
41
Serious AEs
2.4%
Results posted
Apr 2015
Primary outcome: Primary: Induration Size as a Response to Intracutaneous Candida Albicans. — 4; 6; 5; 4 millimeters — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intracutaneous injection of Candida albicans antigen. (Other); Temperature measurement. (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Maastricht University Medical Center
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Induration Size as a Response to Intracutaneous Candida Albicans. |
4; 6; 5; 4; 2; 0 | 0.84 |
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 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.
Data sourced from ClinicalTrials.gov (NCT01370837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.