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

NCT06976073 | Recruiting

• 2 other identifiers: TCI-P3-LMV_220623CIV-22-07-039907
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 3

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. 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Association between IMD-derived variables and markers for circulatory deficiencies measured by CE-marked reference systems

  Evaluate the correlation between IMD-derived parameters and outcomes related to vascular function, including ankle-brachial index, toe-brachial index and tcpO2, acquired by CE-marked reference system Perimed® Periflux 6000 or CE-marked oscillometric ABI measurement device.

  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)

  Assess performance in prediction of cardiovascular disease risk when adding parameters from the clinical study "Cardio Alpha" to parameters from the present study. Outcomes will include known CVD or CVD risk, based on established risk factors, risk scores, clinical information and outcomes from reference devices from both investigations.

  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 (6)

• Association between peak oxygen saturation measured by spatial frequency domain imaging (SFDI) on the palm and forearm and cardiovascular risk factors.

  Typically 3-6 months from enrolment. If 1-year follow-up, then 1 year and 3-6 months from enrolment.

• Correlation between oxygenation on sole of the foot and tissue ischemia level

  Same day as enrolment.

• Correlation between oxygenation on sole of the foot and neuropathy

  Same day as enrolment.

• Correlation between water concentration on sole of the foot and tissue ischemia level

  Same day as enrolment.

• Correlation between water concentration on sole of the foot and neuropathy

  Same day as enrolment.

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HJN Sverige AB/Neko Health: lead

Study Sites (3)

Atrium Health Care Centre

Stockholm, Sweden

RECRUITING

Neko Health Centre, Regeringsgatan

Stockholm, Sweden

RECRUITING

Neko Health Centre, Sibyllegatan

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Foot; Peripheral Arterial Disease; Skin Neoplasms

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Neoplasms by Site; Neoplasms

Study Officials

• Samuel Rodgers, MD

  HJN Sverige AB/Neko Health AB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Windå, MSc

CONTACT

+46703169040; mattias@nekohealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: May 16, 2025
• Study Start: February 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)