NCT01370837

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started May 2012

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

April 10, 2015

Completed
Last Updated

May 6, 2015

Status Verified

April 1, 2015

Enrollment Period

2.7 years

First QC Date

June 7, 2011

Results QC Date

March 30, 2015

Last Update Submit

April 16, 2015

Conditions

Diabetes MellitusPolyneuropathiesArthropathy, Neurogenic

Outcome Measures

Primary Outcomes (1)

  • Induration Size as a Response to Intracutaneous Candida Albicans.

    48 hours after injection.

Study Arms (3)

Healthy controls

EXPERIMENTAL
Other: Intracutaneous injection of Candida albicans antigen.Other: Temperature measurement.

Diabetes

EXPERIMENTAL

Patients with diabetes mellitus without polyneuropathy.

Other: Intracutaneous injection of Candida albicans antigen.Other: Temperature measurement.

Polyneuropathy

EXPERIMENTAL

Patients with diabetes and polyneuropathy.

Other: Intracutaneous injection of Candida albicans antigen.Other: Temperature measurement.

Interventions

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.

DiabetesHealthy controlsPolyneuropathy
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.

DiabetesHealthy controlsPolyneuropathy

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Previous adverse reaction to Candida albicans antigen.
  • Pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 31557355DERIVED

MeSH Terms

Conditions

Diabetes MellitusPolyneuropathiesArthropathy, Neurogenic

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesJoint DiseasesMusculoskeletal Diseases

Results Point of Contact

Title
Kristy Pickwell
Organization
Maastricht University Medical Center
k.pickwell@mumc.nl
+31433877019

Study Officials

  • Nicolaas Schaper, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 10, 2011

Study Start

May 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

May 6, 2015

Results First Posted

April 10, 2015

Record last verified: 2015-04

Locations

NL(1)