Spectrum 1
Most skin conditions affect and/or are caused by the skin's microcirculation (blood flow in the smallest vessels). Skin microcirculation is also affected by many systemic diseases, such as diabetes and autoimmune diseases.
Diseases of large vessels (macrocirculation) can also be caused by fundamental problems with microcirculation.
Today, there are few opportunities for early detection of microcirculation problems and they are often detected when the course of the systemic disease is quite advanced.
This clinical trial will evaluate a study device that uses a projector to image a light pattern on the skin, which the skin absorbs, reflects and scatters depending on the composition and structure of the skin.
Some of the data points collected in this experiment:
- Oxy-hemoglobin (oxidized hemoglobin) concentration
- Deoxyhemoglobin (non-oxidized hemoglobin)
- Total hemoglobin
- Oxygenation within the measured skin area
- Water concentration within the measured skin area
- Melanin concentration
The basic survey takes about 1 minute and the extended one about 30 minutes.
You will also be asked to provide demographic information about yourself and provide a blood sample that will be used in the evaluation of all study subjects.
How does the study work?
The examinations take place in connection with a visit to our clinics. Before the visit, you will have been asked about the study and given this study information. You will then be given time to read the document and the opportunity to ask questions. If you choose to participate in the study, delegated study staff at the trial site will obtain your written consent and register your data in a study protocol.
The test device (system tested in this study) uses a non-contact sensor method. A projector is used to image patterns on the skin. The skin absorbs, reflects and scatters these light patterns depending on the composition and structure of the skin within the examined skin volume. Cameras are then used to image reflected light and the data is used to model the scattering and absorption properties of the skin.
The measurement is non-contact and is made against the inside of the forearm. Prior to measurement, blood flow in the upper arm can be temporarily restricted using a blood pressure cuff, or the temperature can be temporarily changed (heat provocation at 44°C) using an external probe (transducer) over the area of skin being measured by the sensor. These temporary changes are medically approved for the purpose.
In case you are included in one of the study subgroups, you will also undergo measurements with a reference system in parallel with the test device.
The study protocol is supplemented with demographic data and data from the medical record (gender, age, blood pressure, height, weight, smoking, and clinical data from the current care event obtained from the medical record. This includes clinical lab results (e.g. Hb, CRP) and other recorded diseases.
The measurements take about 30 minutes in total.
Why should I participate in Atrium's research programme?
We are a healthcare provider striving to develop new methods and services that can help you meet your long-term health goals. We are interested in exploring how and in what way medical technology can influence future diagnostics and follow-up. Repeated measurements over time provide us with the necessary data to create new insights. At the same time, our doctors will be able to monitor and follow the development of your health condition based on individual risk factors.
