Status:
RECRUITING
Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
Lead Sponsor:
HJN Sverige AB/Neko Health
Conditions:
Diabetes Mellitus, Type 2
Diabetic Foot
Eligibility:
All Genders
18+ years
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 ...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
8000 Patients enrolled
Trial Details
Trial ID
NCT06976073
Start Date
February 1 2023
End Date
January 1 2026
Last Update
May 16 2025
Active Locations (3)
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1
Atrium Health Care Centre
Stockholm, Sweden
2
Neko Health Centre, Regeringsgatan
Stockholm, Sweden
3
Neko Health Centre, Sibyllegatan
Stockholm, Sweden