Diabetes Mellitus, Type 2Spectrum1NCT06976073
Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
An observational study of Diabetes Mellitus, Type 2 and Diabetic Foot, run by HJN Sverige AB/Neko Health at 3 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Foot, Peripheral Arterial Disease
- How many people
- 8,000 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Feb 2023to 1 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study participants mainly consist of a prospective primary care population. 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. An extended investigation will be offered to participants judged to have an increased risk of cardiovascular disease in the primary care population, or for separately invited subjects with increased cardiovascular risk, or as healthy controls. Repeated yearly measurements plan to be performed in interested subjects.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Atrium Health Care Centre
Stockholm
Andreea Valdman, MD, +4673 939 27 11, andreea@nekohealth.com
Samuel Rodgers, MBBS
- Recruiting
Neko Health Centre, Regeringsgatan
Stockholm
Andreea Valdman, MD, +4673 939 27 11, andreea@nekohealth.com
Samuel Rodgers, MBBS
- Recruiting
Neko Health Centre, Sibyllegatan
Stockholm
Andreea Valdman, MD, +4673 939 27 11, andreea@nekohealth.com
Samuel Rodgers, MBBS
About this study
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:
- 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.
- 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.
Read the detailed description
The clinical investigation aims to evaluate the potential value of an investigational medical device (IMD) based on a technology called SFDI, Spatial Frequency Domain Imaging. This is a non-invasive contactless technology for in-vivo measurement of the structure and molecular composition of the skin and its embedded blood volume. The technology is a promising tool for diagnostic support of pathology to the microcirculation, like in peripheral arterial disease and diabetes, but also for general cardiovascular disease risk assessment.
The IMD can measure the concentration of deoxy- and oxyhemoglobin, melanin and water, as well as structural properties in skin tissue, at two imaging depths.
The study participants mainly consist of a prospective primary care population, that undergo an investigation (including SFDI assessment) at a primary care visit. Other assessment data collected during the visit (including medical history, blood pressure, blood values, ankle-brachial index) is retrieved from the participant's medical journal. An extended examination (including SFDI assessment with addition of a 3-minute post-occlusive hyperemia (PORH) test and vascular assessment using the reference system Perimed Periflux 6000) will be offered to participants based on increased risk of cardiovascular disease in the primary care population, or for separately invited subjects with increased cardiovascular risk, known diabetes or as healthy controls. Repeated yearly measurements may be performed in subjects who are interested in doing so.
A subset of participants will undergo a multi-modal investigation which includes combining data from the current study with contactless laser vibrometry data from the investigation "Cardio Alpha" (CIV ID: CIV-22-08-040426). The hypothesis is that cardiovascular disease (CVD) risk assessment may be improved through a multi-modal approach, combining data on both macro- and microcirculatory function.
Another subset of participants will undergo a diabetic feet assessment protocol, including an SFDI assessment of the soles of the feet and assessment using reference methods for macro-and microcirculation, and a foot neuropathy assessment.
A third subset of participants will undergo a skin cancer assessment protocol, including SFDI assessment of a suspected lesion on the skin.
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Foot, Peripheral Arterial Disease, Skin Cancer, Cardiovascular Disease Risk
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Foot, Peripheral Arterial Disease, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patient_cohort | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between IMD-derived variables and markers for circulatory deficiencies measured by CE-marked reference systems
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.
Measured: 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.
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)
Assess performance in prediction of cardiovascular disease risk when adding parameters from the clinical study "Cardio Alpha" to parameters from the present study. Outcomes will include known CVD or CVD risk, based on established risk factors, risk scores, clinical information and outcomes from reference devices from both investigations.
Measured: Same day as enrolment or typically within 3-6 months following enrolment. If 1-year follow-up, then typically 1 year and 3-6 months from enrolment.
Secondary outcomes (6)
Association between peak oxygen saturation measured by spatial frequency domain imaging (SFDI) on the palm and forearm and cardiovascular risk factors.
To evaluate the association between peak oxygenation obtained from the investigational device upon release of a 3-minute post-occlusive hyperemia (PORH) test, and established CVD risk factors, including brachial blood pressure, BMI, hypertension diagnosis, diabetes mellitus diagnosis, smoking status, hsCRP and HbA1C, in a large cohort within primary care.
Measured: Typically 3-6 months from enrolment. If 1-year follow-up, then 1 year and 3-6 months from enrolment.
Correlation between oxygenation on sole of the foot and tissue ischemia level
To evaluate correlation between markers of oxygenation (oxygen conc., total hemoglobin conc., oxy-and deoxy-hemoglobin conc.) on the foot sole and transcutaneous oxygen pressure (tcpO2), acquired using Perimed® Periflux 6000 reference device, in diabetic subjects.
Measured: Same day as enrolment.
Correlation between oxygenation on sole of the foot and neuropathy
To evaluate the correlation between markers of oxygenation (oxygen conc., total hemoglobin conc., oxy-and deoxy-hemoglobin conc.) on foot sole and degree of neuropathy assessed by VibroSense® Meter II neuropathy score, in diabetic subjects.
Measured: Same day as enrolment.
Correlation between water concentration on sole of the foot and tissue ischemia level
Regression coefficient from correlation between water concentration within measured volume on foot sole and transcutaneous oxygen pressure (tcpO2), acquired using Perimed® Periflux 6000 reference device
Measured: Same day as enrolment.
Correlation between water concentration on sole of the foot and neuropathy
Regression coefficient from correlation between melanin and water concentration within measured volume on foot sole and degree of neuropathy assessed by VibroSense® Meter II neuropathy score.
Measured: Same day as enrolment.
Difference in oxygenation/ hemoglobin gradient between lesion and surrounding tissue
Relative gradient in oxy- and deoxy-hemoglobin concentration, total hemoglobin concentration and/or oxygen concentration in malignant and non-malignant skin lesions compared to surrounding tissue.
Measured: At follow-up, within 3 months of enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Feb 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HJN Sverige AB/Neko Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Rodgers, MD, Principal investigator, HJN Sverige AB/Neko Health AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976073
- Sponsor's protocol ID
- TCI-P3-LMV_220623
- Other IDs
- CIV-22-07-039907
- Acronym
- Spectrum1
- Status last verified
- Apr 2025
- First submitted
- 28 Jul 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Imaging for In-vivo Quantification of Skin Composition and Structure
- ClinicalTrials.gov ID
- NCT06976073
- Acronym / sponsor ID
- Spectrum1 / TCI-P3-LMV_220623
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Foot, Peripheral Arterial Disease, Skin Cancer, Cardiovascular Disease Risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- HJN Sverige AB/Neko HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 16 May 2025 (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 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:
- 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.
- 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.
Detailed description
The clinical investigation aims to evaluate the potential value of an investigational medical device (IMD) based on a technology called SFDI, Spatial Frequency Domain Imaging. This is a non-invasive contactless technology for in-vivo measurement of the structure and molecular composition of the skin and its embedded blood volume. The technology is a promising tool for diagnostic support of pathology to the microcirculation, like in peripheral arterial disease and diabetes, but also for general cardiovascular disease risk assessment.
The IMD can measure the concentration of deoxy- and oxyhemoglobin, melanin and water, as well as structural properties in skin tissue, at two imaging depths.
The study participants mainly consist of a prospective primary care population, that undergo an investigation (including SFDI assessment) at a primary care visit. Other assessment data collected during the visit (including medical history, blood pressure, blood values, ankle-brachial index) is retrieved from the participant's medical journal. An extended examination (including SFDI assessment with addition of a 3-minute post-occlusive hyperemia (PORH) test and vascular assessment using the reference system Perimed Periflux 6000) will be offered to participants based on increased risk of cardiovascular disease in the primary care population, or for separately invited subjects with increased cardiovascular risk, known diabetes or as healthy controls. Repeated yearly measurements may be performed in subjects who are interested in doing so.
A subset of participants will undergo a multi-modal investigation which includes combining data from the current study with contactless laser vibrometry data from the investigation "Cardio Alpha" (CIV ID: CIV-22-08-040426). The hypothesis is that cardiovascular disease (CVD) risk assessment may be improved through a multi-modal approach, combining data on both macro- and microcirculatory function.
Another subset of participants will undergo a diabetic feet assessment protocol, including an SFDI assessment of the soles of the feet and assessment using reference methods for macro-and microcirculation, and a foot neuropathy assessment.
A third subset of participants will undergo a skin cancer assessment protocol, including SFDI assessment of a suspected lesion on the skin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient_cohort | – | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study participants mainly consist of a prospective primary care population. 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. An extended investigation will be offered to participants judged to have an increased risk of cardiovascular disease in the primary care population, or for separately invited subjects with increased cardiovascular risk, or as healthy controls. Repeated yearly measurements plan to be performed in interested subjects.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between IMD-derived variables and markers for circulatory deficiencies measured by CE-marked reference systems
Time frame: 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.
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.
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)
Time frame: Same day as enrolment or typically within 3-6 months following enrolment. If 1-year follow-up, then typically 1 year and 3-6 months from enrolment.
Assess performance in prediction of cardiovascular disease risk when adding parameters from the clinical study "Cardio Alpha" to parameters from the present study. Outcomes will include known CVD or CVD risk, based on established risk factors, risk scores, clinical information and outcomes from reference devices from both investigations.
6 secondary outcomes
Association between peak oxygen saturation measured by spatial frequency domain imaging (SFDI) on the palm and forearm and cardiovascular risk factors.
Time frame: Typically 3-6 months from enrolment. If 1-year follow-up, then 1 year and 3-6 months from enrolment.
Correlation between oxygenation on sole of the foot and tissue ischemia level
Time frame: Same day as enrolment.
Correlation between oxygenation on sole of the foot and neuropathy
Time frame: Same day as enrolment.
Correlation between water concentration on sole of the foot and tissue ischemia level
Time frame: Same day as enrolment.
Correlation between water concentration on sole of the foot and neuropathy
Time frame: Same day as enrolment.
Difference in oxygenation/ hemoglobin gradient between lesion and surrounding tissue
Time frame: At follow-up, within 3 months of enrolment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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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.
Samuel Rodgers, MD principal investigator
HJN Sverige AB/Neko Health AB
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Diabetic Foot, run by HJN Sverige AB/Neko Health at 3 sites 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mattias Windå, MSc (+46703169040, mattias@nekohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between IMD-derived variables and markers for circulatory deficiencies measured by CE-marked reference systems (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.