The primary objective is to investigate the intra- and inter-session reliability and construct validity of the FootWork Pro platform and in-shoe system in neuropathic diabetic patients. The secondary objective is to investigate the feasibility of…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intra-class correlation coefficients of several pressure measurement parameters
Secondary outcome
The degree to which the scores of the FootWork Pro PMS are consistent with a
priori formulated theoretical hypotheses (construct validity).
Background summary
Pressure Measurement Systems (PMS) are frequently used in research to objectify
plantar pressure and evaluate conservative treatment in neuropathic diabetic
patients. PMS are valuable tools since it is known that increased plantar
pressure is a causal factor for foot ulcers in this patient population. The
FootWork Pro PMS are frequently used in clinical practice. However unknown is
whether they provide reliable and valid information in clinical practice in
neuropathic diabetic patients.
Study objective
The primary objective is to investigate the intra- and inter-session
reliability and construct validity of the FootWork Pro platform and in-shoe
system in neuropathic diabetic patients. The secondary objective is to
investigate the feasibility of the protocol to measure pressure measurement
parameters with the FootWork Pro platform and in-shoe system in neuropathic
diabetic patients.
Study design
Cross-sectional study
Study burden and risks
There are low risks for participants associated with participation in this
study. Measurements (walking and standing on PMS) belong to usual podiatry
care. Barefoot walking and standing might theoretically slightly increase the
risk of ulceration. However, the risk will be negligible due to the short
measurement times. In addition, to minimize any risk of ulceration, the study
location will be clear of (sharp) objects, there will be sufficient rest
between repeated measurements and the researchers will check for redness and
other skin features that may indicate overload. The burden of participants
falls within acceptable limits and consists of two short measurement moments
(+/- 25 minutes) within two weeks. There is no randomization, no behavioral
changes are imposed and there is no invasive intervention.
Meibergdreef 9
Amsterdam Zuidoost 1105 AZ
NL
Meibergdreef 9
Amsterdam Zuidoost 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Presence of diabetic peripheral neuropathy, indicated by insensitivity to a 10
g Semmes-Weinstein Monofilament for at least two out of three times at the
hallux, first metatarsal head or fifth metatarsal head.
Exclusion criteria
Unable to walk or stand (barefoot)
Use a walking aid
Current foot ulcer
Bilaterale amputation proximal to the metatarsals
Non-diabetic neurological deficit
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 | NL74536.018.20 |