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Photoacoustic Imaging for Diabetic Feet


- candidate number27749
- NTR NumberNTR6616
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-aug-2017
- Secondary IDsNL62903.044.17 ABR-formulier dossiernummer
- Public TitlePhotoacoustic Imaging for Diabetic Feet
- Scientific TitleAssessment of microcirculation in the diabetic foot with photoacoustic imaging
- ACRONYM
- hypothesisDiabetic 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.
- Healt Condition(s) or Problem(s) studiedDiabetic foot, Microcirculation, Ulcer
- 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-okt-2017
- planned closingdate1-okt-2018
- Target number of participants30
- Interventions 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.
- Primary outcomeThe 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 outcomeSecondary 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.
- TimepointsOne measurement of approximately 60-90 minutes
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. O. A. Mennes
- CONTACT for SCIENTIFIC QUERIESDrs. O. A. Mennes
- Sponsor/Initiator Ziekenhuisgroep Twente - Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Ziekenhuisgroep Twente - Department of Surgery
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD15-aug-2017 - 19-aug-2017


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