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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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27438
Enrollment
30
Registered
2019-09-13
Start date
2019-09-13
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Peripheral arterial disease

Interventions

None listed

Sponsors

UMCG
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy volunteers: - 18 years and older - Written informed consent - Rutherford classification 0 Patients with PAD: - 18 years and older - Written informed consent - Claudicants, Rutherford classification 2 and 3. - Chronic limb-threatening disease, Rutherford classification 4 to 6

Exclusion criteria

Exclusion criteria: Healthy volunteers: - Investigations or treatment for cardiovascular disease - Symptoms or history of peripheral neuropathy Both healthy volunteers and patients with PAD: - 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

MeasureTime frame
To develop a standardized and optimized measurement protocol for EPOS measurements, including location on the lower leg, to optimize precision and accuracy of measurements.

Secondary

MeasureTime frame
The second objective is to correlate hemoglobin oxygen saturation(%), red blood cell tissue fraction (%) and the speed resolved RBC perfusion separated into three speed regions; 0-1 mm/s, 1-10 mm/s and above 10 mm/s (% mm/s) with TcPO2 in healthy volunteers, claudicants and patients with chronic limb-threatening ischemia.

Contacts

Public ContactKirsten Ma

UMCG

k.f.ma@umcg.nl0655256492

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)