Investigate the stability and reproducibility of PAI when applied to the diabetic foot. Further, we aim to compare results from PAI with the currently used non-invasive blood pressure measurements.
ID
Source
Brief title
Condition
- Diabetic complications
- Skin vascular abnormalities
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters wil be the perfusion imagies accuared with
Photoacoustic Imaging and the non-invacive blood pressure measurements.
Secondary outcome
not applicable
Background summary
Diabetic foot ulcers are a major complication of diabetes mellitus, high
morbidity, mortality, and costs. Healing times of diabetic foot ulcers are
longest when critical ischemia is present. Critical ischemia is diagnosed by
using non-invasive assessment of blood flow in the feet, by means of the ankle
pressure, toe pressure or transcutaneous oxygen measurements (tcpO2). Cut-off
values for these measurements are given in the international guidelines,
showing the probability of healing without vascular intervention. However,
current non-invasive measurement systems have various disadvantages. Improving
diagnostic assessment of the microcirculation of the diabetic foot is therefore
needed. Photoacoustic Imaging (PAI) is a promising technique for the
visualisation of blood in tissue. With PAI microcirculation in the outermost
layers of the skin can be measured, and these measurements can be performed
closer to the ulcer location. PAI is frequently used in assessment of
microcirculation. However, it has never been applied to the diabetic foot. A
pilot study applying PAI to the diabetic foot is therefore needed.
Study objective
Investigate the stability and reproducibility of PAI when applied to the
diabetic foot. Further, we aim to compare results from PAI with the currently
used non-invasive blood pressure measurements.
Study design
This study is a single centre observational study.
Study burden and risks
Non-invasive blood pressure measurements will be performed and a total of eight
phoacoustic images will be made. During the PAI measurements, different
occlusion tests will be performed to measure the microcirculation of the foot
and stability of PAI. The burden for the patients is minimal. There is no
individual benefit for the patients participating in this study and it is
expected that there are no risks or adverse outcomes for the subjects beside
temporary discomfort.
Zilvermeeuw 1
Almelo 7609 PP
NL
Zilvermeeuw 1
Almelo 7609 PP
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with a diabetic foot ulcer
- Patients with diabetes mellitus, type I or type II
- Aged 18 years or more
- Presence of the hallux or second toe on both the left and the right foot for
toe-pressure measurements
Exclusion criteria
- Presence of an ulcer on both feet
- Diagnosed with an infected foot ulcer
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 | NL62903.044.17 |
| OMON | NL-OMON26755 |