Diabetes MellitusNCT01370837
Neurogenic Inflammation in Diabetes
A study testing Intracutaneous injection of Candida albicans antigen. and Temperature measurement. in people with Diabetes Mellitus and Polyneuropathies, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Polyneuropathies, Arthropathy, Neurogenic
- What is being tested?
- Intracutaneous injection of Candida albicans antigen. and Temperature measurement.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6202 AZ
About this study
Official title: Neurogenic Inflammation in Diabetic Polyneuropathy and Charcot Neuro-osteoarthropathy: Response to Intracutaneous Candida Albicans
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.
- Conditions
- Diabetes Mellitus, Polyneuropathies, Arthropathy, Neurogenic
- Being tested
- Intracutaneous injection of Candida albicans antigen., Temperature measurement.
- Medical subject headings
- Diabetes Mellitus, Polyneuropathies, Arthropathy, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Experimental | Not described Receives: Other: Intracutaneous injection of Candida albicans antigen.; Other: Temperature measurement. |
| Diabetes | Experimental | Patients with diabetes mellitus without polyneuropathy. Receives: Other: Intracutaneous injection of Candida albicans antigen.; Other: Temperature measurement. |
| Polyneuropathy | Experimental | Patients with diabetes and polyneuropathy. Receives: Other: Intracutaneous injection of Candida albicans antigen.; Other: Temperature measurement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induration Size as a Response to Intracutaneous Candida Albicans.
Measured: 48 hours after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startMay 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Responsible party
- Principal investigator, Kristy Pickwell, Maastricht University Medical Center
- Investigators
- Nicolaas Schaper, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370837
- Sponsor's protocol ID
- METC 11-2-044
- Status last verified
- Apr 2015
- First submitted
- 7 Jun 2011
- Last updated
- 6 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 31557355
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurogenic Inflammation in Diabetic Polyneuropathy and Charcot Neuro-osteoarthropathy: Response to Intracutaneous Candida Albicans
- ClinicalTrials.gov ID
- NCT01370837
- Acronym / sponsor ID
- METC 11-2-044
- Conditions
- Diabetes Mellitus, Polyneuropathies, Arthropathy, Neurogenic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Study start
- May 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Posted 10 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Experimental | Other: Intracutaneous injection of Candida albicans antigen., Other: Temperature measurement. |
| Diabetes | Experimental | Other: Intracutaneous injection of Candida albicans antigen., Other: Temperature measurement.Patients with diabetes mellitus without polyneuropathy. |
| Polyneuropathy | Experimental | Other: Intracutaneous injection of Candida albicans antigen., Other: Temperature measurement.Patients with diabetes and polyneuropathy. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diabetes, Healthy controls, Polyneuropathy |
| 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. | Other | Diabetes, Healthy controls, Polyneuropathy |
Primary outcome
Induration Size as a Response to Intracutaneous Candida Albicans.
Time frame: 48 hours after injection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31557355Pickwell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolaas Schaper, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracutaneous injection of Candida albicans antigen. and Temperature measurement. in people with Diabetes Mellitus and Polyneuropathies, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induration Size as a Response to Intracutaneous Candida Albicans. (time frame: 48 hours after injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01370837, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.