Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dutch Diabetes Research Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy controls | Experimental |
| |
| Diabetes | Experimental | Patients with diabetes mellitus without polyneuropathy. |
|
| Polyneuropathy | Experimental | Patients with diabetes and polyneuropathy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracutaneous injection of Candida albicans antigen. | Other | Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot. |
| Measure | Description | Time Frame |
|---|---|---|
| Induration Size as a Response to Intracutaneous Candida Albicans. | 48 hours after injection. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicolaas Schaper, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6202 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31557355 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Controls | 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. 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. |
| FG001 | Diabetes | Patients with diabetes mellitus without polyneuropathy. 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. 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. |
| FG002 | Polyneuropathy | Patients with diabetes and polyneuropathy. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Controls | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Induration Size as a Response to Intracutaneous Candida Albicans. | Posted | Median | 95% Confidence Interval | millimeters | 48 hours after injection. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Controls | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction to Candida antigen | Skin and subcutaneous tissue disorders |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristy Pickwell | Maastricht University Medical Center | +31433877019 | k.pickwell@mumc.nl |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D011115 | Polyneuropathies |
| D001177 | Arthropathy, Neurogenic |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Temperature measurement. | Other | 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. |
|
| BG001 | Diabetes | Patients with diabetes mellitus without polyneuropathy. 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. 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. |
| BG002 | Polyneuropathy | Patients with diabetes and polyneuropathy. 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. 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Polyneuropathy | Patients with diabetes and polyneuropathy. 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. 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. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Diabetes | Patients with diabetes mellitus without polyneuropathy. 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. 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. | 0 | 12 | 0 | 12 |
| EG002 | Polyneuropathy | Patients with diabetes and polyneuropathy. 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. 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. | 1 | 17 | 0 | 17 |
Not provided
Not provided
Not provided
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |