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

NCT ID: NCT06976073

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 8000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-01-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patient_cohort

Adult patients mainly from a primary care cohort. 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. All participants undergo at least one examination with the investigational device (TCI P3).

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HJN Sverige AB/Neko Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Rodgers, MD

Role: PRINCIPAL_INVESTIGATOR

HJN Sverige AB/Neko Health AB

Locations

Atrium Health Care Centre

Stockholm, , Sweden

Site Status: RECRUITING

Neko Health Centre, Regeringsgatan

Stockholm, , Sweden

Site Status: RECRUITING

Neko Health Centre, Sibyllegatan

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Mattias Windå, MSc

Role: CONTACT

mattias@nekohealth.com

+46703169040

Facility Contacts

Andreea Valdman, MD

Role: primary

andreea@nekohealth.com

+4673 939 27 11

Andreea Valdman, MD

Role: primary

andreea@nekohealth.com

+4673 939 27 11

Andreea Valdman, MD

Role: primary

andreea@nekohealth.com

+4673 939 27 11

Other Identifiers

CIV-22-07-039907

Identifier Type: OTHER

Identifier Source: secondary_id

TCI-P3-LMV_220623

Identifier Type: -

Identifier Source: org_study_id