Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lumbar sympathetic blockade.
- Who it may be relevant to
- Registry conditions: Chronic Limb-Threatening Ischemia. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovakia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment
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.
Interventions
- Procedure lumbar sympathetic blockade
Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic
Primary outcome measures
- Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 3m [Time frame: 3 months follow-up]
- Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 6m [Time frame: 6 months follow-up]
- 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 6m [Time frame: 6 months follow-up]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovakia · 1 center
- Europainclinics — Košice
Publications
- 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 39960937
Identifiers
NCT: NCT06111599 · 4/2023/VUSCH/EK