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…
ID
Source
Brief title
Condition
- Diabetic complications
- Epidermal and dermal conditions
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
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 external 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.
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:
1. determining a patients risk of decubitus,
2. confirming the hypothesis that in polyneuropathy patients the inflammatory
response to external 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). The tests will take 2 aftertoons, each of 4,5 hours. During
the first afternoon 100 mmHg of mechanical pressure will be applied to the skin
of the arm of healthy volunteers for 2 hours 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. On the second afternoon (about a week after the first
afternoon) the non-dominant will be loaded for 1 hour with 200 mmHg. After that
the dominant arm will be loaded with 100 mmHg.
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.
Postbus 5800
6202 AZ Maastricht
Nederland
Postbus 5800
6202 AZ 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
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 | NL20191.068.07 |