search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Measurement of cytokines after pressure application.


- candidate number2910
- NTR NumberNTR1167
- ISRCTNWordt niet aangevraagd/Observational study
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-nov-2007
- Secondary IDsMEC 07-2-097 MEC
- Public TitleMeasurement of cytokines after pressure application.
- Scientific TitleMeasurement of cytokines after pressure application.
- ACRONYMMeasurement of cytokines after pressure application.
- hypothesisThere is an increase in concentrations of cytokines IL-1alpha, IL-1RA and IL-8 (as measured using Sebutapes) in the skin of the arm in healthy volunteers after mechanical loading of the skin, compared with an control measurement.
- Healt Condition(s) or Problem(s) studiedDiabetic foot
- Inclusion criteria1. BMI within 18 and 30 kg/m2;
2. age between 18 and 27.
- Exclusion criteria1. Skin diseases like psoriasis or eczema;
2. Diabetes mellitus;
3. Cancer;
4. Muscle disorders;
5. Fractures of the upper extremity;
6. Alcohol or drug abuse;
7. Gravidity;
8. Change of weight >4 kg in the last 4 weeks.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2008
- planned closingdate1-feb-2008
- Target number of participants12
- Interventions100 mmHg of mechanical pressure will be applied to the skin of the arm of healthy volunteers using a an apparatus with an indenter that can apply standardized pressure. Afterwards cytokine measurements will be performed at 5 different times using Sebutapes which are applied to the area of pressure.
- Primary outcomeThe primary study parameters are the measured cytokine concentrations (pg/ml) (after pressure application to the skin).
- Secondary outcomeThe secondary study parameter is the correlation between the time expired after ending the pressure application and the measured cytokine concentrations (pg/ml).
- TimepointsAfter mechanical pressure application cytokine measurements will be performed at t=0, t=30 minutes, t=60 minutes, t=120 minutes and t=24 hours.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Stijn Friederichs
- CONTACT for SCIENTIFIC QUERIESProf. dr. N.C. Schaper
- Sponsor/Initiator Academic Hospital Maastricht, Department of Endocrinology
- Funding
(Source(s) of Monetary or Material Support)
Academic Hospital Maastricht
- PublicationsN/A
- Brief summaryBackground of the study:
1. Decubitus is a common disorder which causes a lot of harm and costs. There is a need of a non-invasive method for detecting patients at risk for developing decubitus. Pro-inflammatory cytokines that are released after mehanical loading are potentially markers for detecting patients at risk;
2. Foot ulcers are a feared complication of diabetes mellitus and occur mainly in polyneuropathy patients. We assume that in polyneuropathy patients the inflammatory response to exogenic stimuli is decreased which predisposes to the development of ulcers and infections;
3. Charcot osteoarthropathy is a rare but very invalidating complication of (diabetic) polyneuropathy, often resulting in a deformed foot. We assume that an excessive inflammatory response, in which pro-inflammatory cytokines play a role, to exogenic stimuli is the underlying mechanism in the development of a acute Charcot foot.


Objective of the study:
The primary goal of this study is to obtain basal knowledge about cytokine concentration in healthy volunteers, after pressure application. In the future we wish to use this knowledge for developing a method for:
1. determining a patients risk of decubitus;
2. confirming the hypothesis that in polyneuropathy patients the inflammatory response to exogenic stimuli is decreased;
3. confirming the hypothesis that the acute Charcot foot develops as a result of a excessive inflammatory response.


Study design:
Pilotstudy (n=12). 100 mmHg of mechanical pressure will be applied to the skin of the arm of healthy volunteers using a an apparatus with an indenter that can apply standardized pressure. Afterwards cytokine measurements will be performed at 5 different times using Sebutapes which are applied to the area of pressure.


Study population:
12 healthy vollunteers. Age between 18 and 27.


Primary study parameters/outcome of the study:
The primary study parameters are the measured cytokine concentrations (pg/ml) (after pressure application to the skin).


Secundary study parameters/outcome of the study:
The secondary study parameter is the correlation between the time expired after ending the pressure application and the measured cytokine concentrations (pg/ml).


Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable): The vollunteers are not exposed tot real risks by cooperating in this study. Earlier studies have shown that the pressure we will apply causes no harm to the skin. Moreover, the mechanical pressure that will be applied does not exceed the pressure that we all are exposed to in our daily lives.
- Main changes (audit trail)
- RECORD23-nov-2007 - 12-nov-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl