NL-OMON27438
Not yet recruiting
Not Applicable
Clinical validation of non-invasive tissue perfusion measurements in Vascular diseased patients with PeriFlux 6000 Enhanced Perfusion and Oxygen Saturation (EPOS) system – Pilot study
MCG0 sites30 target enrollmentTBD
ConditionsPeripheral arterial disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral arterial disease
- Sponsor
- MCG
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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