Chronic Limb-Threatening Ischemia
Conditions
Brief summary
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
PROCEDURElumbar sympathetic blockade
Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic
Sponsors
Slovak Academy of Sciences
Europainclinics z.ú.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with chronic limb-threatening ischemia
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 3m | 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 | 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 | 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 | 6 months follow-up | Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m measured by VAS 10 point measurement |
Countries
Slovakia
Contacts
Primary ContactLadislav Kočan, MD, PhD, FIPP
Outcome results
None listed