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| Name | Class |
|---|---|
| Slovak Academy of Sciences | OTHER_GOV |
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Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Proximal arterial obliteration |
|
| Group B | Experimental | Distal arterial obliteration |
|
| Group C | Experimental | Complex arterial obliteration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lumbar sympathetic blockade | Procedure | Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ladislav Kočan, MD, PhD, FIPP | Contact | +421907440250 | kocanladislav@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Europainclinics | Recruiting | Košice | 04011 | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39960937 | Derived | 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. |
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numerical rating scale of quality of life
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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Patients with chronic limb-threatening ischemia
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |