Clinical Trial

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

Study acronym: Spectrum1
Recruiting
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Record status
This record was last updated May 16, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06976073
Lead Sponsor HJN Sverige AB/Neko Health
Conditions Diabetes Mellitus, Type 2, Diabetic Foot, Peripheral Arterial Disease, Skin Cancer, Cardiovascular Disease Risk
Enrollment 8,000 participants
Start Date 2023-02-01
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-16