Neurogenic Inflammation in Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Maastricht University Medical Center
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: May 2, 2013
Last verified: May 2013
  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
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

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 July 09, 2014