Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2024-03-01
2027-12-31
Brief Summary
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Detailed Description
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The investigational device, TCI P4, is a novel, contactless, non-invasive, non-CE marked, class IIa Spatial Frequency Domain Imaging (SFDI) system. The device utilizes an LED light projector to cast patterned, multi-wavelength light onto the skin while multiple cameras capture narrow-band reflections. This method yields two-dimensional data on skin structure and molecular composition (including hemoglobin, oxygen, and water). Established comparators such as laser speckle contrast imaging (LSCI) and the EPOS system are employed to benchmark device performance and validate measurements.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Severe diabetic microangiopathy
Severe micro-angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers. Aged 18-60 years old.
No interventions assigned to this group
Moderate diabetic microangiopathy
Moderate non-proliferative retinopathy or proliferative retinopathy, macroalbuminuria or kidney failure defined as estimated glomerular filtration rate \<60 mL/min/1.73 m2 body surface, and manifest neuropathy. Aged 18-45 years old.
No interventions assigned to this group
Mild diabetic microangiopathy
Mild-moderate non-proliferative retinopathy and/or microalbuminuria and/or early signs of neuropathy. Aged 18-45 years old.
No interventions assigned to this group
No diabetic microangiopathy
No microangiopathic complications, except for simplex or background retinopathy, which is an early and reversible state. Aged 18-45 years old.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients unable to understand patient information due to language barriers.
* Ongoing acute infection disease or inflammatory condition.
* Pregnant or breast-feeding women.
* Patients with damaged and/or scarred tissue in the areas of interest for the investigational or comparator devices.
18 Years
60 Years
ALL
Yes
Sponsors
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Neko Health AB
UNKNOWN
Karolinska Institutet
OTHER
Responsible Party
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Sara Tehrani
Principal investigator, Medical doctor, Specialist in internal medicine
Locations
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Danderyd University Hospital
Danderyd, Stockholm County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-02232-01
Identifier Type: -
Identifier Source: org_study_id
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