Neurogenic Inflammation in Diabetes (NCT01370837) | Clinical Trial Compass
CompletedNot Applicable
Neurogenic Inflammation in Diabetes
Netherlands41 participantsStarted 2012-05
Plain-language 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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Induration Size as a Response to Intracutaneous Candida Albicans.