Clinical trial · Observational
Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiovascular Disease Risk | — | UNRESOLVED | — |
| Diabetes Mellitus, Type 2 | — | UNRESOLVED | — |
| Diabetic Foot | — | UNRESOLVED | — |
| Peripheral Arterial Disease | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- patient_cohort
- description
- 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).
Primary outcomes (2)
- measure
- Association between IMD-derived variables and markers for circulatory deficiencies measured by CE-marked reference systems
- timeFrame
- 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.
- description
- 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.
- measure
- 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)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available