The goal of this clinical investigation is to explore a non-invasive technology for measuring the microcirculatory structure, composition and function in patients from a primary care population.
The main aims are:
1. To evaluate the robustness of the technology for assessment of the molecular composition and structure of the skin tissue and microcirculatory function, on a prospective primary care population. 2. To evaluate the device and method on its capability to detect deficiencies in circulation, compared with existing reference systems with similar characteristics for patients with known cardiovascular disease risk and/or diabetes.
Adult patients part of the regular healthcare patient flow at the investigational sites, or as separately invited to participate in this investigation.
Patients with signed informed consent
Cognitive impairment
Patients unable to understand the oral and written study information in Swedish or English
Other severe disorder or terminal disease
Patients unable to provide an informed consent
The study participants mainly consist of a prospective primary care population. All patients visiting the clinical sites, seeking care, or as separately invited, are offered to participate in this investigation. This includes sub-groups of patients with conditions such as diabetes mellitus, peripheral arterial disease and skin cancer. An extended investigation will be offered to participants judged to have an increased risk of cardiovascular disease in the primary care population, or for separately invited subjects with increased cardiovascular risk, or as healthy controls. Repeated yearly measurements plan to be performed in interested subjects.
Cohort
Prospective
Not listed
Association between IMD-derived variables and markers for circulatory deficiencies measured by CE-marked reference systems
Evaluate the correlation between IMD-derived parameters and outcomes related to vascular function, including ankle-brachial index, toe-brachial index and tcpO2, acquired by CE-marked reference system Perimed® Periflux 6000 or CE-marked oscillometric ABI measurement device.
Performance of a combined risk score using data from Spectrum 1 and the in parallel performed investigation "Cardio Alpha"(CIV-ID: CIV-22-08-040426)
Assess performance in prediction of cardiovascular disease risk when adding parameters from the clinical study "Cardio Alpha" to parameters from the present study. Outcomes will include known CVD or CVD risk, based on established risk factors, risk scores, clinical information and outcomes from reference devices from both investigations.
Association between peak oxygen saturation measured by spatial frequency domain imaging (SFDI) on the palm and forearm and cardiovascular risk factors.
To evaluate the association between peak oxygenation obtained from the investigational device upon release of a 3-minute post-occlusive hyperemia (PORH) test, and established CVD risk factors, including brachial blood pressure, BMI, hypertension diagnosis, diabetes mellitus diagnosis, smoking status, hsCRP and HbA1C, in a large cohort within primary care.
Correlation between oxygenation on sole of the foot and tissue ischemia level
To evaluate correlation between markers of oxygenation (oxygen conc., total hemoglobin conc., oxy-and deoxy-hemoglobin conc.) on the foot sole and transcutaneous oxygen pressure (tcpO2), acquired using Perimed® Periflux 6000 reference device, in diabetic subjects.
Correlation between oxygenation on sole of the foot and neuropathy
To evaluate the correlation between markers of oxygenation (oxygen conc., total hemoglobin conc., oxy-and deoxy-hemoglobin conc.) on foot sole and degree of neuropathy assessed by VibroSense® Meter II neuropathy score, in diabetic subjects.
Correlation between water concentration on sole of the foot and tissue ischemia level
Regression coefficient from correlation between water concentration within measured volume on foot sole and transcutaneous oxygen pressure (tcpO2), acquired using Perimed® Periflux 6000 reference device
Click on the lead sponsor to view all of their trials.
