NCT06976073 Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
| NCT ID | NCT06976073 |
| Status | Recruiting |
| Phase | — |
| Sponsor | HJN Sverige AB/Neko Health |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 8,000 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2026-01-01 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Patient´s with damaged, scarred or non-intact skin within the skin area of interest.
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