Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment
Tevi-LuSy
1 other identifier
interventional
60
1 country
1
Brief Summary
Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2023
CompletedStudy Start
First participant enrolled
October 22, 2023
CompletedFirst Posted
Study publicly available on registry
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedNovember 1, 2023
October 1, 2023
9 months
October 21, 2023
October 26, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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 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 3m
Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 3m measured by VAS 10 point measurement
3 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
Study Arms (3)
Group A
EXPERIMENTALProximal arterial obliteration
Group B
EXPERIMENTALDistal arterial obliteration
Group C
EXPERIMENTALComplex arterial obliteration
Interventions
Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Europainclinics z.ú.lead
- Slovak Academy of Sciencescollaborator
Study Sites (1)
Europainclinics
Košice, 04011, Slovakia
Related Publications (1)
Kocan L, Rajtukova V, Rasiova M, Kocanova H, Hudak R, Vaskova J, Satnik V, Martuliak I, Hudak M. Infrared monitoring-based optimization of interventional lumbar sympathectomy outcomes evaluation in peripheral vascular disease patients: Experimental trial thermovision-guided lumbar sympathectomy. Medicine (Baltimore). 2025 Feb 14;104(7):e41524. doi: 10.1097/MD.0000000000041524.
PMID: 39960937DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2023
First Posted
November 1, 2023
Study Start
October 22, 2023
Primary Completion
August 1, 2024
Study Completion (Estimated)
August 31, 2026
Last Updated
November 1, 2023
Record last verified: 2023-10