Non-invasive imaging to measure skin composition and structure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation explores a non-invasive technology called Spatial Frequency Domain Imaging (SFDI) to assess the microcirculatory structure and function of skin tissue in a primary care population. The study aims to evaluate the technology's ability to measure molecular composition, including levels of deoxy- and oxyhemoglobin, melanin, and water, as well as structural properties at different depths. Participants will undergo SFDI assessments during routine primary care visits, with additional evaluations for those at increased cardiovascular risk or with diabetes. The study also compares SFDI results with existing reference systems to validate its effectiveness.

Why it matters

Who can join: the full rules

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.

Where it's running

• Atrium Health Care Centre
  Stockholm, Sweden Recruiting
• Neko Health Centre, Regeringsgatan
  Stockholm, Sweden Recruiting
• Neko Health Centre, Sibyllegatan
  Stockholm, Sweden Recruiting

Study contacts

• Principal investigator: Samuel Rodgers, MD — HJN Sverige AB/Neko Health AB
• Study coordinator: Mattias Windå, MSc
• Email: mattias@nekohealth.com
• Phone: +46703169040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.