Clinical trial NCT06976073: Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
Official title: Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Diabetic Foot
Peripheral Arterial Disease
Skin Cancer
Cardiovascular Disease Risk
Lead sponsor: HJN Sverige AB/Neko Health
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: The clinical investigation aims to evaluate the potential value of an investigational medical device (IMD) based on a technology called SFDI, Spatial Frequency Domain Imaging. This is a non-invasive contactless technology for in-vivo measurement of the structure and molecular composition of the skin and its embedded blood volume. The technology is a promising tool for diagnostic support of pathology to the microcirculation, like in peripheral arterial disease and diabetes, but also for general cardiovascular disease risk assessment.

The IMD can measure the concentration of deoxy- and oxyhemoglobin, melanin and water, as well as structural properties in skin tissue, at two imaging depths.

The study participants mainly consist of a prospective primary care population, that undergo an investigation (including SFDI assessment) at a primary care visit. Other assessment data collected during the visit (including medical history, blood pressure, blood values, ankle-brachial index) is retrieved from the participant's medical journal. An extended examination (including SFDI assessment with addition of a 3-minute post-occlusive hyperemia (PORH) test and vascular assessment using the reference system Perimed Periflux 6000) will be offered to participants based on increased risk of cardiovascular disease in the primary care population, or for separately invited subjects with increased cardiovascular risk, known diabetes or as healthy controls. Repeated yearly measurements may be performed in subjects who are interested in doing so.

A subset of participants will undergo a multi-modal investigation which includes combining data from the current study with contactless laser vibrometry data from the investigation "Cardio Alpha" (CIV ID: CIV-22-08-040426). The hypothesis is that cardiovascular disease (CVD) risk assessment may be improved through a multi-modal approach, combining data on both macro- and microcirculatory function.

Another subset of participants will undergo a diabetic feet assessment protocol, including an SFDI assessment of the soles of the feet and assessment using reference methods for macro-and microcirculation, and a foot neuropathy assessment.

A third subset of participants will undergo a skin cancer assessment protocol, including SFDI assessment of a suspected lesion on the skin.

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.

Primary outcomes:
measure: Association between IMD-derived variables and markers for circulatory deficiencies measured by CE-marked reference systems
timeFrame: 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.
measure: 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)
timeFrame: 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.
Secondary outcomes:
measure: Association between peak oxygen saturation measured by spatial frequency domain imaging (SFDI) on the palm and forearm and cardiovascular risk factors.
timeFrame: Typically 3-6 months from enrolment. If 1-year follow-up, then 1 year and 3-6 months from enrolment.
measure: Correlation between oxygenation on sole of the foot and tissue ischemia level
timeFrame: Same day as enrolment.
measure: Correlation between oxygenation on sole of the foot and neuropathy
timeFrame: Same day as enrolment.
measure: Correlation between water concentration on sole of the foot and tissue ischemia level
timeFrame: Same day as enrolment.
measure: Correlation between water concentration on sole of the foot and neuropathy
timeFrame: Same day as enrolment.
measure: Difference in oxygenation/ hemoglobin gradient between lesion and surrounding tissue
timeFrame: At follow-up, within 3 months of enrolment.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Atrium Health Care Centre
city: Stockholm
country: Sweden
facility: Neko Health Centre, Regeringsgatan
city: Stockholm
country: Sweden
facility: Neko Health Centre, Sibyllegatan
Study officials:
affiliation: HJN Sverige AB/Neko Health AB
name: Samuel Rodgers, MD
role: PRINCIPAL_INVESTIGATOR
References: