Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06111599

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Limb-Threatening Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Europainclinics

Košice, 04011, Slovakia

Location status: Recruiting

Location contact

Ladislav Kočan, MD PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lumbar sympathetic blockade

Procedure

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

Primary outcomes

  1. Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 3m

    Time frame: 3 months follow-up

    EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

  2. Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 6m

    Time frame: 6 months follow-up

    EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression

  3. Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 3m

    Time frame: 3 months follow-up

    Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 3m measured by VAS 10 point measurement

  4. Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m

    Time frame: 6 months follow-up

    Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement

Study contacts

Contact information is provided by the study sponsor or research team.

Ladislav Kočan, MD, PhD, FIPP

CONTACT

[email protected]

+421907440250

Sponsors and collaborators

Lead sponsor

EPC Education s.r.o.

Other

Collaborators

  • Slovak Academy of Sciences

Registry information

Acronym: Tevi-LuSy

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.