Chronic Limb-Threatening IschemiaTevi-LuSyNCT06111599
Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment
A study testing lumbar sympathetic blockade in people with Chronic Limb-Threatening Ischemia, run by EPC Education s.r.o. at 1 site in Slovakia.
Trial summary
Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Limb-Threatening Ischemia
- What is being tested?
- lumbar sympathetic blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSlovakia
- Study dates
- 22 Oct 2023to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovakia1 site, 1 recruiting
- Recruiting
Europainclinics
Košice, 04011
Ladislav Kočan, MD PhD
About this study
Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment
Read the 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.
- Conditions
- Chronic Limb-Threatening Ischemia
- Being tested
- lumbar sympathetic blockade
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar sympathetic blockadeProcedure or surgery
Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Proximal arterial obliteration Receives: Procedure: lumbar sympathetic blockade |
| Group B | Experimental | Distal arterial obliteration Receives: Procedure: lumbar sympathetic blockade |
| Group C | Experimental | Complex arterial obliteration Receives: Procedure: lumbar sympathetic blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 3m
EQ-5D-5L self-care, usual activities, pain/discomfort and anxiety/depression
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start22 Oct 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Limb-Threatening IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with chronic limb-threatening ischemia
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Collaborators
- Slovak Academy of Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111599
- Sponsor's protocol ID
- 4/2023/VUSCH/EK
- Acronym
- Tevi-LuSy
- Status last verified
- Oct 2023
- First submitted
- 21 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: numerical rating scale of quality of life
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.
PubMed 39960937
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment
- ClinicalTrials.gov ID
- NCT06111599
- Acronym / sponsor ID
- Tevi-LuSy / 4/2023/VUSCH/EK
- Conditions
- Chronic Limb-Threatening Ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Collaborators
- Slovak Academy of Sciences
- Study start
- 22 Oct 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients with chronic limb-threatening ischemia
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: lumbar sympathetic blockadeProximal arterial obliteration |
| Group B | Experimental | Procedure: lumbar sympathetic blockadeDistal arterial obliteration |
| Group C | Experimental | Procedure: lumbar sympathetic blockadeComplex arterial obliteration |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumbar sympathetic blockadeSkiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Derived from this study: PubMed 39960937Kocan 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.
- Individual participant dataSharing planned: Undecided. numerical rating scale of quality of life
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar sympathetic blockade in people with Chronic Limb-Threatening Ischemia, run by EPC Education s.r.o. at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ladislav Kočan, MD, PhD, FIPP (+421907440250, kocanladislav@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 3m (time frame: 3 months follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06111599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.