Neurogenic Inflammation in Diabetes

This study has been completed.
Sponsor:
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: April 16, 2015
Last verified: April 2015
  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.
Other: Temperature measurement.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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: 48 hours after injection. ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: May 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Experimental: 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.
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.
Experimental: 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.
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370837

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6202 AZ
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
Results First Received: March 30, 2015
Last Updated: April 16, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Arthropathy, Neurogenic
Neurogenic Inflammation
Polyneuropathies
Inflammation
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on July 05, 2015