Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment (Tevi-LuSy)

Europainclinics z.ú.

Status: Enrolling

Conditions: Chronic Limb-Threatening Ischemia

Treatments: Procedure: lumbar sympathetic blockade

Study type: Interventional

Funder types: Other

Identifiers

NCT06111599

4/2023/VUSCH/EK

Details and patient eligibility

About

Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment

Full description

Chronic limb-threatening ischemia (CLTI), the end-stage of lower extremity artery disease (LEAD), occurs with growing prevalence around the globe and is associated with increased healthcare costs. CLTI is defined by the presence of LEAD in combination with rest pain, gangrene, or lower limb ulceration lasting more than two weeks. Despite unclear results of abdominal surgical lumbar sympathectomy, novel interventional minimally invasive fluoroscopy-guided procedures seem to be promising. A prospective interventional study will be conducted, primarily targeting patients afflicted by critical limb ischemia, with the incorporation of thermal vision control and tissue oxygen monitoring.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic limb-threatening ischemia-Patients with chronic leg pain for at least 6 months with intensity (VAS >=5)
• those who (only if a signature was obtainable), or whose legal guardian,fully understood the clinical trial -details and signed the informed consent form

Exclusion criteria

• Chronic Venous Insufficiency
• women with positive a pregnancy tests before the trial or who planned to become pregnant within the following 3 years
• other patients viewed as inappropriate by the staff
• disagreement with participation in the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Group A

Experimental group

Description:

Proximal arterial obliteration

Treatment:

Procedure: lumbar sympathetic blockade

Group B

Experimental group

Description:

Distal arterial obliteration

Treatment:

Procedure: lumbar sympathetic blockade

Group C

Experimental group

Description:

Complex arterial obliteration

Treatment:

Procedure: lumbar sympathetic blockade