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…
ID
Bron
Aandoening
Ulcer, Diabetic foot, Microcirculation,
Wond, Diabetische voet, Microcirculatie
Ondersteuning
Department of Surgery<br>
Zilvermeeuw 1<br>
7609 PP Almelo
Department of Surgery<br>
Zilvermeeuw 1<br>
7609 PP Almelo
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Doel van het onderzoek
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.
Onderzoeksopzet
One measurement of approximately 60-90 minutes
Onderzoeksproduct en/of interventie
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.
Publiek
O. A. Mennes
Zilvermeeuw 1
Almelo 7609 PP
The Netherlands
088-708 3727
o.mennes@zgt.nl
Wetenschappelijk
O. A. Mennes
Zilvermeeuw 1
Almelo 7609 PP
The Netherlands
088-708 3727
o.mennes@zgt.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Presence of an ulcer on both feet
• Diagnosed with an infected foot ulcer
Opzet
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Register | ID |
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NTR-new | NL6274 |
NTR-old | NTR6616 |
CCMO | NL62903.044.17 |
OMON | NL-OMON48969 |