Status:
SUSPENDED
Comparative Measurement of Microcirculation and Other Parameters With the Vital USA VitalDetect™ in Patients With Diabetes Mellitus Type 1 and Type 2 Versus Healthy Participants
Lead Sponsor:
Sciema UG
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The purpose of this clinical study is to optimize the measurement algorithm of the Vital USA VitalDetectTM in measuring the microcirculating blood flow. Further optimization and finally the demonstrat...
Detailed Description
The study procedures will be the same for all three groups during the single visit. In all groups of participants, the Vital USA VitalDetect™ will be individually introduced and assigned. During the e...
Eligibility Criteria
Inclusion
- Type 1 or Type 2 diabetic or healthy subject (25 Type 1, 25 Type 2, 50 healthy subjects)
- Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
- 18 years old and above;
- Anatomically suitable finger in discretion of the investigator
Exclusion
- Does not meet inclusion criteria;
- Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars, tattoos;
- Pregnancy;
- Nursing mothers;
- Any skin scratch(es), damage, over dry, long nails on the measured finger;
- Unsuitable finger with the device might be excluded if recognized during the trial;
- Medication containing nitrates
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06063759
Start Date
September 25 2023
End Date
November 30 2023
Last Update
October 3 2023
Active Locations (1)
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1
PSHI Praxis GmbH
Mainz, Germany, 55128