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 confirming the hypothesis that in…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters are the measured cytokine concentrations (pg/ml)
(after pressure application to the skin).
Secondary outcome
The secondary study parameter is the correlation between the time expired after
ending the pressure application and the measured cytokine concentrations
(pg/ml).
Background summary
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.
Study objective
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 confirming the
hypothesis that in polyneuropathy patients the inflammatory response to
exogenic stimuli is decreased.
Study design
Pilotstudy (n=20). 100 mmHg of mechanical pressure will be applied to the skin
of the foot 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 burden and risks
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.
P. Debyelaan 25
6229 HX Maastricht
Nederland
P. Debyelaan 25
6229 HX Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
age: 18-27
Body mass index within the range of 18-30 kg/m^2
Exclusion criteria
Skin conditions like psoriasis or eczema
Diabetes mellitus
Cancer
Muscle disorders
Upper extremity fractures
Alcohol or drug abuse
Gravidity
Change of weight of more than 4 kg within the last 4 weeks
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23918.068.08 |