Healthy Volunteer Study to Assess Microcirculatory Function

Healthy Clinical Trial

Official title:

Microscopic and Spectroscopic Examination of Skin Microcirculation in Healthy Individuals Using ODI Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05608798
• Other study ID #: CIV-NO-22-08-040389
• Status: Completed
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: December 22, 2023

Study information

• Verified date: April 2024
• Source: ODI Medical AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• ODI-Tech medical device
The device captures and stores frames of the movement of blood in capillaries and spectra containing information on oxygen saturation. Proprietary software is used to analyse the obtained frames and spectra to calculate microvascular parameters such as functional capillary density and microvascular oxygen saturation. ODI-Tech can be brought to the patient's bedside and operates non-invasively. The device parts are in contact with the patient for less than 5 minutes.

Locations

Country	Name	City	State
Norway	ODI Medical	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
ODI Medical AS

Country where clinical trial is conducted

Norway, 

References & Publications (11)

Awan ZA, Haggblad E, Wester T, Kvernebo MS, Halvorsen PS, Kvernebo K. Diffuse reflectance spectroscopy: Systemic and microvascular oxygen saturation is linearly correlated and hypoxia leads to increased spatial heterogeneity of microvascular saturation. Microvasc Res. 2011 May;81(3):245-51. doi: 10.1016/j.mvr.2011.02.004. Epub 2011 Mar 2. — View Citation

Bungum L, Kvernebo K, Oian P, Maltau JM. Laser doppler-recorded reactive hyperaemia in the forearm skin during the menstrual cycle. Br J Obstet Gynaecol. 1996 Jan;103(1):70-5. doi: 10.1111/j.1471-0528.1996.tb09517.x. — View Citation

Fredly S, Fugelseth D, Nygaard CS, Salerud EG, Stiris T, Kvernebo K. Noninvasive assessments of oxygen delivery from the microcirculation to skin in hypothermia-treated asphyxiated newborn infants. Pediatr Res. 2016 Jun;79(6):902-6. doi: 10.1038/pr.2016.16. Epub 2016 Feb 8. — View Citation

Fredly S, Fugelseth D, Wester T, Haggblad E, Kvernebo K. Skin microcirculation in healthy term newborn infants--assessment of morphology, perfusion and oxygenation. Clin Hemorheol Microcirc. 2015;59(4):309-22. doi: 10.3233/CH-131764. — View Citation

Kvernebo AK, Miyamoto T, Sporastoyl AH, Wikslund LK, Masoy SE, Drolsum L, Moe MC, Salerud G, Fukamachi K, Kvernebo K. Quantification of ocular surface microcirculation by computer assisted video microscopy and diffuse reflectance spectroscopy. Exp Eye Res. 2020 Dec;201:108312. doi: 10.1016/j.exer.2020.108312. Epub 2020 Oct 22. — View Citation

Mork C, Asker CL, Salerud EG, Kvernebo K. Microvascular arteriovenous shunting is a probable pathogenetic mechanism in erythromelalgia. J Invest Dermatol. 2000 Apr;114(4):643-6. doi: 10.1046/j.1523-1747.2000.00944.x. — View Citation

Mork C, Kvernebo K, Asker CL, Salerud EG. Reduced skin capillary density during attacks of erythromelalgia implies arteriovenous shunting as pathogenetic mechanism. J Invest Dermatol. 2002 Oct;119(4):949-53. doi: 10.1046/j.1523-1747.2002.00218.x. — View Citation

Mork C, Salerud EG, Asker CL, Kvernebo K. The prostaglandin E1 analog misoprostol reduces symptoms and microvascular arteriovenous shunting in erythromelalgia-a double-blind, crossover, placebo-compared study. J Invest Dermatol. 2004 Mar;122(3):587-93. doi: 10.1111/j.0022-202X.2004.22339.x. — View Citation

Staxrud LE, Jakobsson A, Kvernebo K, Salerud EG. Spatial and temporal evaluation of locally induced skin trauma recorded with laser Doppler techniques. Microvasc Res. 1996 Jan;51(1):69-79. doi: 10.1006/mvre.1996.0008. — View Citation

Sundheim LK, Sporastoyl AH, Wester T, Salerud G, Kvernebo K. Acute skin trauma induces hyperemia, but superficial papillary nutritive perfusion remains unchanged. Microcirculation. 2017 Oct;24(7). doi: 10.1111/micc.12389. — View Citation

Wester T, Awan ZA, Kvernebo TS, Salerud G, Kvernebo K. Skin microvascular morphology and hemodynamics during treatment with veno-arterial extra-corporeal membrane oxygenation. Clin Hemorheol Microcirc. 2014;56(2):119-31. doi: 10.3233/CH-131670. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Capillary Density (FCD)	Expressed as mean value	Day 1, 2 assessments, minimum 1 hour between
Primary	Heterogeneity of FCD	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.	Day 1, 2 assessments, minimum 1 hour between
Primary	Microvascular Oxygen Saturation (SmvO2)	Percent	Day 1, 2 assessments, minimum 1 hour between
Primary	Heterogeneity of SmvO2	[coefficient of variation] within the specific assessment and patient	Day 1, 2 assessments, minimum 1 hour between
Primary	Tissue haematocrit (TH)	Percentage	Day 1, 2 assessments, minimum 1 hour between
Primary	Heterogeneity of TH	[coefficient of variation] within the specific assessment and patient	Day 1, 2 assessments, minimum 1 hour between
Primary	Visual assessment of capillary morphology	dilatation, elongation, microvascular bleedings	Day 1, 2 assessments, minimum 1 hour between
Secondary	Incidence of AE/ADE/SAE/SADE/DD	Descriptive as number of reported, graded	Day 1
Secondary	Reproducibility	Variance of FCD, SmvO2 and its associated heterogeneity between measurements	Day 1