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

Sponsor

Europainclinics z.ú. (Other)

Overall Status

Recruiting

CT.gov ID

NCT06111599

Collaborator

Slovak Academy of Sciences (Other)

Enrollment

Location

Arms

34.3

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Limb-Threatening Ischemia	Procedure: lumbar sympathetic blockade	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients with chronic limb-threatening ischemiaPatients with chronic limb-threatening ischemia

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 22, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 31, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 EuroQoL-5 Dimension (EQ-5D) Value 6m [6 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 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Europainclinics	Košice		Slovakia	04011

Sponsors and Collaborators

Europainclinics z.ú.
Slovak Academy of Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Europainclinics z.ú.

ClinicalTrials.gov Identifier:

NCT06111599

Other Study ID Numbers:

4/2023/VUSCH/EK

First Posted:

Nov 1, 2023

Last Update Posted:

Nov 1, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Limb-Threatening Ischemia

Ischemia

Study Results

No Results Posted as of Nov 1, 2023