NL-OMON48610
Recruiting
N/A
Prospective Registration Of Critical Leg Ischemia Outcomes in the Netherlands - PROCLIO
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 502
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Critical limb ischemia is defined as following;
- •Patients must have ischemic rest pain, tissue loss, ulcer or gangrene. Symptoms
- •have to be present for more than two weeks at time of enrollment. PAD must be
- •confirmed by one of the following;
- •\* Absolute systolic ankle pressure \< 70 mmHg
- •\* Systolic Toe Pressure \< 50 mmHg
- •\* Transcutaneous oxygen pressure (tcPO2\) \< 50 mmHg
- •\* One or more significant (\>50%) obstructions in the iliac or lower limb
- •arteries as found with non\-invasive imaging (duplex ultrasonography (DUS),
- •Magnetic Resonance Angiography (MRA), Computed Tomography Angiography (CTA)) or
Exclusion Criteria
- •In the case of meeting any of the following criteria patients will be excluded
- •from enrollment.
- •\* Acute ischemia; due to emboli or trauma
- •\* Non\-atherosclerotic origin of ischemia; arteritis, thrombangitis obliterans
- •(Buerger\*s disease)
- •\* Hypercoagulable states
- •\* Venous ulcer
- •\* Insufficient proficiency of Dutch language, or inability to complete the
- •Dutch questionnaires
- •\* In the case of bilateral affected limbs, the least affected limb will be
Outcomes
Primary Outcomes
Not specified
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