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Clinical Trials/NL-OMON27438
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

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
MCG

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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