Microangiopathy in Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorKarolinska Institutet
About this trial
This clinical trial aims to evaluate the use of a contactless and non-invasive technique to measure the properties of the skin's microcirculation and its regulatory functions in both healthy individuals and patients with microvascular disease associated with type 1 diabetes. It is hoped that the study results will lead to the development of a useful method for detecting diabetic complications at an early stage, thereby enabling treatment and preventive measures before the onset of severe microangiopathy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diabetes mellitus type 1.
Cohort specific inclusion criteria apply, please review 'groups' section.
Disqualifiers
Patients unable to understand patient information due to cognitive impairment.
Patients unable to understand patient information due to language barriers.
Ongoing acute infection disease or inflammatory condition.
Pregnant or breast-feeding women.
Trial population
Outpatient at Danderyd Hospital Diabetes Clinic
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 4 trial groupsGroup A: Severe diabetic microangiopathy
Group B: Moderate diabetic microangiopathy
Group C: Mild diabetic microangiopathy
Group D: No diabetic microangiopathy
Trial outcomes
Primary outcomes
1
Peak perfusion in response to local thermal hyperemia
As measured with investigational devices TCI P4, Pericam LSCI and EPOS devices.
Time frame
Investigation will take within 1 day from enrollment.Secondary outcomes
1
Perfusion heterogeneity in sole of feet
Perfusion heterogeneity index as measured by investigational device TCI P4. It will be stated as a numerical ordinal scale.
Time frame
Investigation will take place within 1 day from enrollment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Neko Health AB
Collaborator
Source ClinicalTrials.gov