Clinical validation of non-invasive tissue perfusion measurements in Vascular diseased patients with PeriFlux 6000 Enhanced Perfusion and Oxygen Saturation (EPOS) system * Pilot study

Clinical validation of non-invasive tissue perfusion measurements in Vascular diseased patients with PeriFlux 6000 Enhanced Perfusion and Oxygen Saturation (EPOS) system * Pilot study - The VEPOS study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48139

Enrollment

Registered

2019-11-26

Start date

2020-09-07

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constricted bloodflow to the legs Intermittent claudication

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 years and older and written informed consent with either; - Healthy volunteer, Rutherford classification 0 - Non- critical limb ischemia, Rutherford classification 2 and 3. - Critical limb ischemia, Rutherford classification 4 to 6.

Exclusion criteria

Exclusion criteria: - Insufficient knowledge of the Dutch language, illiteracy or language barrier - Concurrent uncontrolled medical conditions - Lower leg fractures within the past 12 months. - (Partial) amputation of one of the feet and/or legs. - Pregnant or breast feeding. - Severe peripheral oedema. - Severe cardiac-pulmonary failure. - Active cellulitis-erysipelas of the legs or other dermatological diseases.

Design outcomes

Primary

Measure	Time frame
The main endpoint of this pilot study is the feasibility and clinical performance of measurement at three different locations on the foot and lower let with the EPOS system and a standardized measurement protocol for EPOS measurements.	—

Secondary

Measure	Time frame
The second study parameter is to determine baseline values of oxygen saturation, RBC tissue fraction, and speed resolved RBC perfusion, which are measured with the EPOS system, for the three groups of participants. Factors that may affect skin perfusion will be noted, including tobacco smoking (pack years and daily consumption), coffee consumption (both global and on measurement day), daily activity (both global and on measurement day), systemic blood pressure, local skin temperature, and arterial oxygen saturation, diabetes mellitus, COPD, and cardiovascular disease. Other secondary goals are the comparison of EPOS measurements with tcpo2 measurements and standard non-invasive methods as skin temperature, saturation and arterial blood pressure measurements.	—

Measure

Time frame

The second study parameter is to determine baseline values of oxygen saturation, RBC tissue fraction, and speed resolved RBC perfusion, which are measured with the EPOS system, for the three groups of participants. Factors that may affect skin perfusion will be noted, including tobacco smoking (pack years and daily consumption), coffee consumption (both global and on measurement day), daily activity (both global and on measurement day), systemic blood pressure, local skin temperature, and arterial oxygen saturation, diabetes mellitus, COPD, and cardiovascular disease. Other secondary goals are the comparison of EPOS measurements with tcpo2 measurements and standard non-invasive methods as skin temperature, saturation and arterial blood pressure measurements.

—

Countries

Netherlands

Outcome results