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

Chronic Limb-Threatening Ischemia Clinical Trial

— Tevi-LuSy  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111599
• Other study ID #: 4/2023/VUSCH/EK
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: October 2023
• Source: Europainclinics z.ú.
• Contact: Ladislav Kocan, MD, PhD, FIPP
• Phone: +421907440250
• Email: kocanladislav[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2026
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Ischemia

Intervention

Procedure:
• lumbar sympathetic blockade
Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic

Locations

Country	Name	City	State
Slovakia	Europainclinics	Košice

Sponsors (2)

Lead Sponsor	Collaborator
Europainclinics z.ú.	Slovak Academy of Sciences

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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