NCT05570019

Evaluation of Tissue Perfusion in Peripheral Arterial Disease (EVTI-PAD)

Evaluation of Tissue Perfusion in Patients With Lower Extremity Peripheral Arterial Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Peripheral Arterial Disease
• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia

Interventions

Type	Name	Description
PROCEDURE	Revascularization	Open surgery (arterial endarterectomy with or without bypass surgery) and/or angioplasty (with or without stent placement)

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2022-10-06
• Last updated: 2024-03-13

Locations

1 site across 1 country: Austria