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Clinical Trials/NL-OMON51744
NL-OMON51744
Not Yet Recruiting
N/A

Perfusion monitoring in lower limbs of patients with peripheral arterial occlusive disease with continuous ICG video angiography - A pilot study - PERFUSE

niversitair Medisch Centrum Groningen0 sites20 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Peripheral arterial occlusive disease
Sponsor
niversitair Medisch Centrum Groningen
Enrollment
20
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 invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • \- Written informed consent
  • \- Rutherford class 4\-6
  • \- Occlusion at the level of the iliac or femoral arteries
  • \- Unilateral disease. Control leg must have an ABI \>\= 0\.8, no rest pain, and no

Exclusion Criteria

  • \- Insufficient knowledge of the Dutch language, illiteracy, or language barrier.
  • \- Lower leg fracture within the past 12 months.
  • \- (Partial) amputation of one of the feet and/or legs.
  • \- Known hypersensitivity to indocyanine green or to sodium iodide.
  • \- Hyper\-thyroidism and autonomic thyroid adenomas.
  • \- Renal insufficiency.
  • \- Concomitant use of the following: anticonvulsants, bisulphite compounds,
  • haloperidol, heroin, meperidine, metamizole, methadone, morphium,
  • nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, cyclopropane,
  • probenecid, and rifamycin.

Outcomes

Primary Outcomes

Not specified

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