No registrations found.
ID
Source
Health condition
Ulcer, Diabetic foot, Microcirculation,
Wond, Diabetische voet, Microcirculatie
Sponsors and support
Department of Surgery<br>
Zilvermeeuw 1<br>
7609 PP Almelo
Department of Surgery<br>
Zilvermeeuw 1<br>
7609 PP Almelo
Intervention
Outcome measures
Primary outcome
The main study parameters will be perfusion images of the diabetic foot with LSCI. The stability and intra- and inter- reproducibility of the LSCI technique will be measured and compared with non-invasive blood pressure measurements.
Secondary outcome
Secondary Objectives:
(1) To investigate the relation of LSCI and currently used non-invasive blood pressure measurements
(2) To investigate the differences in microcirculation between the three groups of patients
(3) To investigate the stability of LSCI relating to (motion) artefacts or reproducibility of occlusion tests.
Study objective
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 design
One measurement of approximately 60-90 minutes
Intervention
Non-invasive blood pressure measurements will be performed and a total of four LSCI will be made. During the LSCI two occlusion tests will be performed to measure the microcirculation of the foot and stability of LSCI. There are no known risks associated with blood pressure measurements or LSCI, beside temporary discomfort.
O. A. Mennes
Zilvermeeuw 1
Almelo 7609 PP
The Netherlands
088-708 3727
o.mennes@zgt.nl
O. A. Mennes
Zilvermeeuw 1
Almelo 7609 PP
The Netherlands
088-708 3727
o.mennes@zgt.nl
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
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6274 |
NTR-old | NTR6616 |
CCMO | NL62903.044.17 |
OMON | NL-OMON48969 |