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

Completed

Conditions: Constricted bloodflow to the legs
Intermittent claudication
10003216

Registration Number: NL-OMON48139

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

- 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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this pilot study is the feasibility and clinical<br /><br>performance of measurement at three different locations on the foot and lower<br /><br>let with the EPOS system and a standardized measurement protocol for EPOS<br /><br>measurements.</p><br>

Secondary Outcome Measures

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