Prospective Registration Of Critical Leg Ischemia Outcomes in the Netherlands

Recruiting

Conditions: peripheral arterial disease
peripheral vascular disease
10003184
10003216

Registration Number: NL-OMON48610

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 502

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
digital subtraction angiography (DSA)
* Written informed consent

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
excluded.
* Ipsilateral peripheral revascularization intervention of the affected limb
within the last three months before presentation

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are amputation free survival (AFS) and patient reported<br /><br>outcomes measures (PROMS) after 12 months follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Wound healing (complete epithelialization)<br /><br>* Overall survival<br /><br>* Limb salvage<br /><br>* Major amputation (proximal to the level of the ankle)<br /><br>* Minor amputation (toe, forefoot)<br /><br>* Resource utilization (outpatient visits, need for rehabilitation, nursing<br /><br>home care).<br /><br>* Events (reinterventions, readmissions)<br /><br>* Cost of care within 12 months</p><br>