Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure

Conditions studied

Diabetes Mellitus, Type 2, Diabetic Foot, Peripheral Arterial Disease, Skin Cancer, Cardiovascular Disease Risk

About this study

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.

Primary outcomes

• Association between IMD-derived variables and markers for circulatory deficiencies measured by CE-marked reference systems (Same day as enrolment, or typically within 3-6 months from enrolment. If 1-year follow-up, then 1 year and 3-6 months from enrolment.)
• 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) (Same day as enrolment or typically within 3-6 months following enrolment. If 1-year follow-up, then typically 1 year and 3-6 months from enrolment.)

Eligibility information

Study locations

• Atrium Health Care Centre, Stockholm, Sweden
• Neko Health Centre, Regeringsgatan, Stockholm, Sweden
• Neko Health Centre, Sibyllegatan, Stockholm, Sweden