The ultimate objective is to develop an intelligent telemedicine monitoring system for early detection of (pre-signs of) ulceration in diabetic feet. The aim of the current project is to come up with a proof of principle of the modalities needed to…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Proof of principle of the combination of modalities and software that can
accurately predict (pre-signs of) ulceration in diabetic feet.
Secondary outcome
- Collection of data from hyperspectral, photometric and thermal measurements,
as well as live assessments, to investigate modalities and develop software for
the proof of principle that is the main study parameter
Background summary
Many patients with diabetes suffer from vascular and neurological complications
in the lower extremities. These conditions significantly increase the risk of
developing foot ulcers, which in turn may lead to foot infection, and
eventually to amputation of (part of) the foot or the lower leg and a loss in
health-related quality of life.
Foot ulcers may be prevented by early detection of (pre-signs of) ulceration.
Therefore, frequent examination of the feet is needed. However,
self-examination is difficult or impossible due to consequences of the
diabetes. Frequent examination by health care professionals is costly and not
feasible.
Regular screening with an automated device, situated at a patient*s home and
capable of warning health professionals when necessary, may reduce ulceration,
and thereby improve patient*s autonomy and health-related quality of life.
Study objective
The ultimate objective is to develop an intelligent telemedicine monitoring
system for early detection of (pre-signs of) ulceration in diabetic feet. The
aim of the current project is to come up with a proof of principle of the
modalities needed to built such a system.
Study design
Observational study.
Study burden and risks
Only a light burden is put on patients by participating in this study.
Measurements take 20 minutes and will be taken before a regular visit to the
diabetic foot outpatient clinic. The measurements do not interfere with regular
treatment. There are no known risks for the patients, as this is an
observational study where only data from hyperspectral, photometric and thermal
measurements of the patient*s feet will be collected with certified and safe
measuring instruments. There are no direct benefits for the patients in
participation. It is essential to perform this study in patients with diabetes,
as the intelligent telemedicine monitoring system will be developed
specifically for these patients.
Postbus 217
7500AE Enschede
NL
Postbus 217
7500AE Enschede
NL
Listed location countries
Age
Inclusion criteria
- diabetes mellitus
- aged 18 years or more
- diagnosed with one of the following foot problems as a consequence of diabetes:
-- ulcer
-- callus
-- red skin
-- higher temperature on the skin of the foot
-- fissure
-- blister
-- crackle skin
Exclusion criteria
None
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL36061.044.11 |
OMON | NL-OMON27099 |