Microscopic and Spectroscopic Examination of Skin Microcirculation in Healthy Individuals Using ODI Technology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- ODI Medical AS
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Tissue haematocrit (TH)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of the study is to obtain microvascular data from a healthy, heterogeneous population for assessing reference values for the parameters Functional Capillary Density (FCD), heterogeneity of FCD, Microvascular Oxygen Saturation (SmvO2) and Heterogeneity of SmvO2 for healthy adults with respect to gender, age, and skin type (Fitzpatrick scale)
Detailed Description
Primary objective: • Obtain reference data of the studied microvascular parameters in a healthy, heterogeneous population Secondary objectives: * Determine the reproducibility of the parameters obtained using the device produced by ODI Medical * Confirm the safety of the device produced by ODI Medical
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects without signs or symptoms of acute or chronic disease and that are not treated with regular medication (contraceptive pills/IUD and oestrogen medication for menopausal symptoms are allowed). Pregnant women can be included.
Exclusion Criteria
- •Regular smokers
- •Misusers of alcohol
- •Misusers of drugs
- •Not intact skin or reddening in the region of interest
Outcomes
Primary Outcomes
Tissue haematocrit (TH)
Time Frame: Day 1, 2 assessments, minimum 1 hour between
Percentage
Heterogeneity of TH
Time Frame: Day 1, 2 assessments, minimum 1 hour between
\[coefficient of variation\] within the specific assessment and patient
Microvascular Oxygen Saturation (SmvO2)
Time Frame: Day 1, 2 assessments, minimum 1 hour between
Percent
Functional Capillary Density (FCD)
Time Frame: Day 1, 2 assessments, minimum 1 hour between
Expressed as mean value
Heterogeneity of FCD
Time Frame: Day 1, 2 assessments, minimum 1 hour between
FCD from each frame is recorded from four quadrants in each frame where the coefficient of variation (CoV) in each frame is calculated, as well as an average CoV based on the 20 values from the same subject and session.
Heterogeneity of SmvO2
Time Frame: Day 1, 2 assessments, minimum 1 hour between
\[coefficient of variation\] within the specific assessment and patient
Visual assessment of capillary morphology
Time Frame: Day 1, 2 assessments, minimum 1 hour between
dilatation, elongation, microvascular bleedings
Secondary Outcomes
- Reproducibility(Day 1)
- Incidence of AE/ADE/SAE/SADE/DD(Day 1)