Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment

Not Applicable

Recruiting

• Conditions: Chronic Limb-Threatening Ischemia
• Interventions: Procedure: lumbar sympathetic blockade

• Registration Number: NCT06111599
• Lead Sponsor: Europainclinics z.ú.

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-21
• Study Start: 2023-10-22
• Study First Submitted QC: 2023-10-26
• Last Update Submitted: 2023-10-26
• Study First Posted: 2023-11-01
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-08-01
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	lumbar sympathetic blockade	Complex arterial obliteration
Group A	lumbar sympathetic blockade	Proximal arterial obliteration
Group B	lumbar sympathetic blockade	Distal arterial obliteration

Primary Outcome Measures

Name	Time	Method
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 3m	3 months follow-up	Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 3m measured by VAS 10 point measurement
Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 3m	3 months follow-up	EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m	6 months follow-up	Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement
Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 6m	6 months follow-up	EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

Trial Locations

Locations (1)

Europainclinics; 🇸🇰 Košice, Slovakia