peripheral arterial disease peripheral vascular disease
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are amputation free survival (AFS) and patient reported outcomes measures (PROMS) after 12 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Wound healing (complete epithelialization) * Overall survival * Limb salvage * Major amputation (proximal to the level of the ankle) * Minor amputation (toe, forefoot) * Resource utilization (outpatient visits, need for rehabilitation, nursing home care). * Events (reinterventions, readmissions) * Cost of care within 12 months | — |
Countries
Netherlands
Outcome results
None listed