Neurogenic Inflammation in Diabetes
This study is currently recruiting participants.
Verified May 2013 by Maastricht University Medical Center
Sponsor:
Maastricht University Medical Center
Collaborator:
Dutch Diabetes Research Foundation
Information provided by (Responsible Party):
Kristy Pickwell, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01370837
First received: June 7, 2011
Last updated: May 2, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus Polyneuropathies Arthropathy, Neurogenic |
Other: Intracutaneous injection of Candida albicans antigen. Procedure: Punch skin biopsy Other: Temperature measurement. |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Neurogenic Inflammation in Diabetic Polyneuropathy and Charcot Neuro-osteoarthropathy: Response to Intracutaneous Candida Albicans |
Resource links provided by NLM:
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- Induration size as a response to intracutaneous Candida albicans. [ Time Frame: 24 hours after injection. ] [ Designated as safety issue: No ]
- Induration size as a response to intracutaneous Candida albicans. [ Time Frame: 48 hours after injection. ] [ Designated as safety issue: No ]
- Induration size as a response to intracutaneous Candida albicans. [ Time Frame: 72 hours after injection. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Temperature at the injection site of the highest concentration of Candida albicans antigen on the foot, compared to the same location on the contralateral foot. [ Time Frame: 24, 48 and 72 hours after injection. ] [ Designated as safety issue: No ]
- Nature of the induration that appears as a response to intracutaneous Candida albicans evaluated by microscopy of a skin biopsy taken at the injection site of the highest concentration of Candida albicans on the foot. [ Time Frame: 72 hours after injection. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | May 2012 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Healthy controls |
Other: Intracutaneous injection of Candida albicans antigen.
Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Procedure: Punch skin biopsy
Biopsy will be taken at the site of injection of the highest concentration of Candida albicans on the foot.
Other: Temperature measurement.
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.
|
|
Diabetes
Patients with diabetes mellitus without polyneuropathy.
|
Other: Intracutaneous injection of Candida albicans antigen.
Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Procedure: Punch skin biopsy
Biopsy will be taken at the site of injection of the highest concentration of Candida albicans on the foot.
Other: Temperature measurement.
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.
|
|
Polyneuropathy
Patients with diabetes and polyneuropathy.
|
Other: Intracutaneous injection of Candida albicans antigen.
Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Procedure: Punch skin biopsy
Biopsy will be taken at the site of injection of the highest concentration of Candida albicans on the foot.
Other: Temperature measurement.
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.
|
|
Charcot
Patients with a history of Charcot's disease.
|
Other: Intracutaneous injection of Candida albicans antigen.
Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Other: Temperature measurement.
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.
|
Eligibility| Ages Eligible for Study: | 40 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Community (healthy controls), primary care facilities (patients with diabetes without polyneuropathy), secondary care facilities (patients with polyneuropathy, patients with a history of Charcot's disease).
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370837
Contacts
| Contact: Kristy Pickwell, MD | +31433877019 | k.pickwell@mumc.nl |
| Contact: Marleen Kars, MD, PhD | +31433877019 | marleen.kars@mumc.nl |
Locations
| Netherlands | |
| Maastricht University Medical Center | Recruiting |
| Maastricht, Limburg, Netherlands, 6202 AZ | |
| Contact: Kristy Pickwell, MD +31433877019 k.pickwell@mumc.nl | |
| Contact: Marleen Kars, MD, PhD +31433877019 marleen.kars@mumc.nl | |
Sponsors and Collaborators
Maastricht University Medical Center
Dutch Diabetes Research Foundation
Investigators
| Principal Investigator: | Nicolaas Schaper, MD, PhD | Maastricht University Medical Center |
More Information
No publications provided
| Responsible Party: | Kristy Pickwell, MD, Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01370837 History of Changes |
| Other Study ID Numbers: | METC 11-2-044 |
| Study First Received: | June 7, 2011 |
| Last Updated: | May 2, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Additional relevant MeSH terms:
|
Arthropathy, Neurogenic Diabetes Mellitus Inflammation Joint Diseases Polyneuropathies Diabetic Neuropathies Neurogenic Inflammation Musculoskeletal Diseases Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pathologic Processes Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Diabetes Complications Neurologic Manifestations |
ClinicalTrials.gov processed this record on May 19, 2013