Healthy SubjectsNCT06009939
Microvascular Sex and Age-related Day-to-day Variability in Healthy Subjects
An observational study of Healthy Subjects, run by Vårdcentralen Åby at 1 site in Sweden.
Trial summary
The goal of this observational study is to learn more about the microcirculation in the skin by examining sex and age-related day-to-day variability in healthy subjects. The main questions the trial aims to answer are: What is the day-to-day variability of the optical measurement techniques in the microcirculation… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Occlusion of the circulation in the arm and foot
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2023to 14 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 12 healthy men and 12 healthy women aged 20-30 years old. 12 healthy men and 12 healthy women aged 50-60 years old. In total 48 participants will be included.
Who may be able to join
- Men and women between 20-30 years old and 50-60 years old
Who cannot join
- Regular use of medication (except for anti-conception medication)
- Hypertension
- Skin- or cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn more about the microcirculation in the skin by examining sex and age-related day-to-day variability in healthy subjects. The main questions the trial aims to answer are:
- What is the day-to-day variability of the optical measurement techniques in the microcirculation, and does age and gender affect this?
- Does the day-to-day variability differ in the foot compared to the arm?
Participants will rest whilst skin measurement by optical measurement techniques are performed. Baseline measurements and post-occlusive reactive hyperemia will be studied on the forearm and foot. This measurement procedure is repeated within one week, in order to study variability.
Read the detailed description
The microcirculation consists of arterioles, capillaries and venules and is essential for nutrients and oxygen to be delivered to the tissue as well as waste products to be removed. The skin is often used as a model for studying microcirculation.
There are many different ways to study the microcirculation, most commonly are noninvasive optical techniques which measures the reflection of light used. Laser Doppler Flowmetry (LDF) has been the golden standard, but one limitation with the technique is that it measures the bloodflow in a small area (about 1 mm3). In this study the investigators will be using single-point measurement with a technique called EPOS and larger area measurements with a technique called PSI-X. EPOS, based on LDF and diffuse reflectance spectroscopy (DRS), analyze speed-resolved perfusion, variations in red blood cell tissue fraction, oxygen saturation and vessel diameter. PSI-X, based on multi-exposure laser speckle contrast imaging (MELSCI) and multispectral imaging (MSI), analyze conventional perfusion, speed-resolved perfusion and oxygen saturation.
Flowmotion is the rhythmical variations in measured skin blood flow that arise due to global and local regulation of the vessels and can be studied using frequency analysis of time-resolved blood flow signals. Since EPOS and PSI-X collect data of time-resolved blood flow, flowmotion analysis will also be conducted in the study.
To study day-to-day variability, data will be collected from each subject on two separate days within seven days, on the same location of the foot as well as the arm. Once the subject arrives to the lab, a questionnaire will be filled in regarding the subjects physical activity level, exercise habits and usage of medication and nicotine. The subject will also confirm to not have eaten two hours and not used nicotine or caffeine three hours prior to the experiment. Thereafter the subject's length and weight will be measured and BMI calculated. The subjects skin type will be determined using the Fitzpatrick scale. All of this is only done on the first day of measurement, on the second day the subject will skip right to the following part.
An acclimatization period of 15 minutes begins and the subject will remove socks and lay down. While the subject rests the equipment will be set up. A blood pressure cuff is placed around the upper arm as well as around the ankle. An EPOS-probe is placed on the dorsal side of the foot as well as the volar side of the forearm. A marker pen is used to mark the skin around the probes which enables the probe to be placed on the same location on the next measurement. Once five minutes has passed, the subject's blood pressure and pulse is noted. Thereafter the PSI-X camera is set up and angled to film the plantar side of the foot from a distance of about 25 cm. The subject is asked to lay as still as possible during the measurement. Once the acclimatization period has passed, the lights in the lab are turned off and the measurement will begin. Firstly baseline data will be collected as the subject rest for 10 minutes without provocation. Thereafter the blood pressure cuff on the ankle will inflate to 250 mmHg for five minutes whilst data is collected. Lastly data is collected for five minutes after the blood pressure cuff deflates. Thereafter the PSI-X camera is moved and angled to film the forearm from a 25 cm distance. The protocol described above is repeated for the arm. The subject will return within seven days to repeat the data collection protocol.
- Conditions
- Healthy Subjects
- Being tested
- Occlusion of the circulation in the arm and foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusion of the circulation in the arm and footOther
A blood pressure cuff occludes the circulation in the upper arm as well as around the ankle.
| Study group | Role | What they receive |
|---|---|---|
| Healthy men aged 20-30 years old | Foot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement.
Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Receives: Other: Occlusion of the circulation in the arm and foot | |
| Healthy women aged 20-30 years old | Foot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement.
Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Receives: Other: Occlusion of the circulation in the arm and foot | |
| Healthy men aged 50-60 years old | Foot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement.
Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Receives: Other: Occlusion of the circulation in the arm and foot | |
| Healthy women aged 50-60 years old | Foot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement.
Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Receives: Other: Occlusion of the circulation in the arm and foot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed-resolved perfusion
[% RBC ×mm/s]
Measured: Measured during 45 minutes and at one more occasion for 45 minutes within one week.
Red blood cell tissue fraction
[% RBC]
Measured: Measured during 45 minutes and at one more occasion for 45 minutes within one week.
Oxygen saturation
[% oxygen]
Measured: Measured during 45 minutes and at one more occasion for 45 minutes within one week.
Vessel diameter
[μm]
Measured: Measured during 45 minutes and at one more occasion for 45 minutes within one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Mar 2023
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vårdcentralen Åby
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Biomedical Engineering (IMT), Department of Health, Medicine and Caring Sciences (HMV), Linkoeping University
- Responsible party
- Principal investigator, Fredrik Iredahl, Vårdcentralen Åby
- Investigators
- Fredrik Iredahl, Principal investigator, Linköping University, Department of Health, Medicine and Caring Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009939
- Sponsor's protocol ID
- 2023-01
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hultman M, Larsson M, Stromberg T, Henricson J, Iredahl F, Fredriksson I. Flowmotion imaging analysis of spatiotemporal variations in skin microcirculatory perfusion. Microvasc Res. 2023 Mar;146:104456. doi: 10.1016/j.mvr.2022.104456. Epub 2022 Nov 18. No abstract available.
PubMed 36403668Fredriksson I, Larsson M, Stromberg T, Iredahl F. Vasomotion analysis of speed resolved perfusion, oxygen saturation, red blood cell tissue fraction, and vessel diameter: Novel microvascular perspectives. Skin Res Technol. 2022 Jan;28(1):142-152. doi: 10.1111/srt.13106. Epub 2021 Nov 10.
PubMed 34758168Hultman M, Larsson M, Stromberg T, Fredriksson I. Real-time video-rate perfusion imaging using multi-exposure laser speckle contrast imaging and machine learning. J Biomed Opt. 2020 Nov;25(11):116007. doi: 10.1117/1.JBO.25.11.116007.
PubMed 33191685Hultman M, Larsson M, Stromberg T, Fredriksson I. Speed-resolved perfusion imaging using multi-exposure laser speckle contrast imaging and machine learning. J Biomed Opt. 2023 Mar;28(3):036007. doi: 10.1117/1.JBO.28.3.036007. Epub 2023 Mar 20.
PubMed 36950019
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Sex and Age-related Day-to-day Variability in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06009939
- Acronym / sponsor ID
- 2023-01
- Conditions
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Vårdcentralen ÅbyUniversity, hospital or other
- Collaborators
- Department of Biomedical Engineering (IMT), Department of Health, Medicine and Caring Sciences (HMV), Linkoeping University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn more about the microcirculation in the skin by examining sex and age-related day-to-day variability in healthy subjects. The main questions the trial aims to answer are:
- What is the day-to-day variability of the optical measurement techniques in the microcirculation, and does age and gender affect this?
- Does the day-to-day variability differ in the foot compared to the arm?
Participants will rest whilst skin measurement by optical measurement techniques are performed. Baseline measurements and post-occlusive reactive hyperemia will be studied on the forearm and foot. This measurement procedure is repeated within one week, in order to study variability.
Detailed description
The microcirculation consists of arterioles, capillaries and venules and is essential for nutrients and oxygen to be delivered to the tissue as well as waste products to be removed. The skin is often used as a model for studying microcirculation.
There are many different ways to study the microcirculation, most commonly are noninvasive optical techniques which measures the reflection of light used. Laser Doppler Flowmetry (LDF) has been the golden standard, but one limitation with the technique is that it measures the bloodflow in a small area (about 1 mm3). In this study the investigators will be using single-point measurement with a technique called EPOS and larger area measurements with a technique called PSI-X. EPOS, based on LDF and diffuse reflectance spectroscopy (DRS), analyze speed-resolved perfusion, variations in red blood cell tissue fraction, oxygen saturation and vessel diameter. PSI-X, based on multi-exposure laser speckle contrast imaging (MELSCI) and multispectral imaging (MSI), analyze conventional perfusion, speed-resolved perfusion and oxygen saturation.
Flowmotion is the rhythmical variations in measured skin blood flow that arise due to global and local regulation of the vessels and can be studied using frequency analysis of time-resolved blood flow signals. Since EPOS and PSI-X collect data of time-resolved blood flow, flowmotion analysis will also be conducted in the study.
To study day-to-day variability, data will be collected from each subject on two separate days within seven days, on the same location of the foot as well as the arm. Once the subject arrives to the lab, a questionnaire will be filled in regarding the subjects physical activity level, exercise habits and usage of medication and nicotine. The subject will also confirm to not have eaten two hours and not used nicotine or caffeine three hours prior to the experiment. Thereafter the subject's length and weight will be measured and BMI calculated. The subjects skin type will be determined using the Fitzpatrick scale. All of this is only done on the first day of measurement, on the second day the subject will skip right to the following part.
An acclimatization period of 15 minutes begins and the subject will remove socks and lay down. While the subject rests the equipment will be set up. A blood pressure cuff is placed around the upper arm as well as around the ankle. An EPOS-probe is placed on the dorsal side of the foot as well as the volar side of the forearm. A marker pen is used to mark the skin around the probes which enables the probe to be placed on the same location on the next measurement. Once five minutes has passed, the subject's blood pressure and pulse is noted. Thereafter the PSI-X camera is set up and angled to film the plantar side of the foot from a distance of about 25 cm. The subject is asked to lay as still as possible during the measurement. Once the acclimatization period has passed, the lights in the lab are turned off and the measurement will begin. Firstly baseline data will be collected as the subject rest for 10 minutes without provocation. Thereafter the blood pressure cuff on the ankle will inflate to 250 mmHg for five minutes whilst data is collected. Lastly data is collected for five minutes after the blood pressure cuff deflates. Thereafter the PSI-X camera is moved and angled to film the forearm from a 25 cm distance. The protocol described above is repeated for the arm. The subject will return within seven days to repeat the data collection protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy men aged 20-30 years old | – | Other: Occlusion of the circulation in the arm and footFoot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. |
| Healthy women aged 20-30 years old | – | Other: Occlusion of the circulation in the arm and footFoot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. |
| Healthy men aged 50-60 years old | – | Other: Occlusion of the circulation in the arm and footFoot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. |
| Healthy women aged 50-60 years old | – | Other: Occlusion of the circulation in the arm and footFoot: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. Arm: 10 minutes of baseline measurement, 5 minutes of occlusion and 5 minutes of Post-occlusive reactive hyperemia (PORH) measurement. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 12 healthy men and 12 healthy women aged 20-30 years old. 12 healthy men and 12 healthy women aged 50-60 years old. In total 48 participants will be included.
Key inclusion criteria (1 listed)
- Men and women between 20-30 years old and 50-60 years old
Key exclusion criteria (3 listed)
- Regular use of medication (except for anti-conception medication)
- Hypertension
- Skin- or cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusion of the circulation in the arm and footA blood pressure cuff occludes the circulation in the upper arm as well as around the ankle. | Other | Healthy men aged 20-30 years old, Healthy men aged 50-60 years old, Healthy women aged 20-30 years old, Healthy women aged 50-60 years old |
Primary outcome
Speed-resolved perfusion
Time frame: Measured during 45 minutes and at one more occasion for 45 minutes within one week.
[% RBC ×mm/s]
Red blood cell tissue fraction
Time frame: Measured during 45 minutes and at one more occasion for 45 minutes within one week.
[% RBC]
Oxygen saturation
Time frame: Measured during 45 minutes and at one more occasion for 45 minutes within one week.
[% oxygen]
Vessel diameter
Time frame: Measured during 45 minutes and at one more occasion for 45 minutes within one week.
[μm]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Background: PubMed 36403668Hultman M, Larsson M, Stromberg T, Henricson J, Iredahl F, Fredriksson I. Flowmotion imaging analysis of spatiotemporal variations in skin microcirculatory perfusion. Microvasc Res. 2023 Mar;146:104456. doi: 10.1016/j.mvr.2022.104456. Epub 2022 Nov 18. No abstract available.
- Background: PubMed 34758168Fredriksson I, Larsson M, Stromberg T, Iredahl F. Vasomotion analysis of speed resolved perfusion, oxygen saturation, red blood cell tissue fraction, and vessel diameter: Novel microvascular perspectives. Skin Res Technol. 2022 Jan;28(1):142-152. doi: 10.1111/srt.13106. Epub 2021 Nov 10.
- Background: PubMed 33191685Hultman M, Larsson M, Stromberg T, Fredriksson I. Real-time video-rate perfusion imaging using multi-exposure laser speckle contrast imaging and machine learning. J Biomed Opt. 2020 Nov;25(11):116007. doi: 10.1117/1.JBO.25.11.116007.
- Background: PubMed 36950019Hultman M, Larsson M, Stromberg T, Fredriksson I. Speed-resolved perfusion imaging using multi-exposure laser speckle contrast imaging and machine learning. J Biomed Opt. 2023 Mar;28(3):036007. doi: 10.1117/1.JBO.28.3.036007. Epub 2023 Mar 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik Iredahl principal investigator
Linköping University, Department of Health, Medicine and Caring Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects, run by Vårdcentralen Åby at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed-resolved perfusion (time frame: Measured during 45 minutes and at one more occasion for 45 minutes within one week.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06009939, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.