In this prospective single-center observational study, arterial perfusion in patients with lower limb peripheral arterial disease will be assessed with standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures (open surgery and/or angioplasty).
Arterial perfusion is an important parameter for the capacity of wound healing in patients with peripheral arterial disease (PAD). Quantifying tissue perfusion in affected patients can help in deciding whether further revascularization is necessary to achieve wound healing and limb salvage. Not only in PAD patients with ulceration, but also in patients with rest pain or life-style limiting claudication, the measurement of arterial perfusion before and after revascularization could influence further treatment regarding surgical/interventional procedures as well as medical treatment. Digital subtraction angiography (DSA) is the gold standard for the evaluation of peripheral arterial outflow and for quality assessment after revascularization. However, angiography only displays the larger arteries and not tissue perfusion itself, which is crucial for wound healing. In this study, the change of tissue perfusion measured with the different standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures will be evaluated.
Study Type
OBSERVATIONAL
Enrollment
200
Open surgery (arterial endarterectomy with or without bypass surgery) and/or angioplasty (with or without stent placement)
Department of Vascular Surgery, Medical University Innsbruck
Innsbruck, Tyrol, Austria
RECRUITINGTranscutaneous oxygen pressure
Change in transcutaneous oxygen pressure is measured before and after the revascularization procedure.
Time frame: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure
WIfI stage
Change in WIfI (wound, ischemia, foot infection) stage is documented before and after the revascularization procedure.
Time frame: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure
Rutherford category
Change in Rutherford category is documented before and after the revascularization procedure.
Time frame: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure
Primary patency
Primary patency of the treated arterial lesion is documented after the procedure
Time frame: Post-procedural (within 5 days) and 3 months after the index procedure
Secondary patency
Secondary patency of the treated arterial lesion is documented after the procedure
Time frame: Post-procedural (within 5 days) and 3 months after the index procedure
Limb salvage
Limb salvage of the treated extremity is documented after the procedure
Time frame: Post-procedural (within 5 days) and 3 months after the index procedure
Ankle-brachial index (ABI)
Change in ABI is documented before and after the revascularization procedure.
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Time frame: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure
Fluorescence angiography
Change in fluorescence angiography is documented before and after the revascularization procedure.
Time frame: Pre-procedural, post-procedural (within 5 days) and 3 months after the index procedure
Survival
Survival of patients after the revascularization.
Time frame: Post-procedural (within 5 days) and 3 months after the index procedure