PETRI: Prehabilitation in the Elderly with chronic limb Threatening Ischemia
- Conditions
- Chronic Limb Threatening Ischemia (CLTI)
- Registration Number
- NL-OMON28123
- Lead Sponsor
- Prof. dr. L. van der Laan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 170
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Aged 65 years or older
-All genders
-All ethnicities
-Diagnosis of CLTI (Chronic Limb Threatening Ischemia), based on either:
oAnamnestic complaints of ischemic rest pain or night pain
o(Minor) tissue loss, non-healing ulcer and/or focal gangrene with diffuse pedal ischemia[11]
oImpaired perfusion, quantified by a flat or barely pulsatile ankle or metatarsal PVR (pulse volume recording), a low resting ankle pressure, a low ankle brachial index and/or a low toe pressure.
-Indication and informed consent to undergo either endovascular or surgical treatment
-No need to start treatment earlier then 3 weeks, counting from the moment of diagnosis
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Dementia according to DSM-V
-Inability to complete questionnaires, due to either lingual or cognitive incompetence.
-Need for urgent surgery (<3 weeks)
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative delirium
- Secondary Outcome Measures
Name Time Method Secondary outcomes will be in-hospital mortality, 30 day, 6 month and 12 month mortality, complications, rates of major amputations, amputation free survival (AFS), length of hospital stay, Quality of Life (QoL, measured by using the WHOQOL-BREF, SF-12 and VascuQoL-6-NL), functional outcome, cognitive function and biochemistry.