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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Limb-Threatening Ischemia
• Intervention / Treatment: Procedure: lumbar sympathetic blockade

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ladislav Kočan, MD, PhD, FIPP; Phone Number: +421907440250; Email: kocanladislav@gmail.com

Study Locations

• Slovakia
  • Košice, Slovakia, 04011
    • Recruiting
    • Europainclinics
    • Contact: Ladislav Kočan, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Proximal arterial obliteration	Procedure: lumbar sympathetic blockade; Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic
Experimental: Group B; Distal arterial obliteration	Procedure: lumbar sympathetic blockade; Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic
Experimental: Group C; Complex arterial obliteration	Procedure: lumbar sympathetic blockade; Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Europainclinics z.ú.
• Collaborators: Slovak Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: October 21, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Peripheral Arterial Disease; Ischemia; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: 4/2023/VUSCH/EK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: numerical rating scale of quality of life

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No