Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment

Study Overview
=================
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.

Official Title
-----------------
Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment

Conditions
-----------------
Chronic Limb-Threatening Ischemia

Intervention / Treatment
-----------------
* Procedure: lumbar sympathetic blockade


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with chronic limb-threatening ischemia
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Proximal arterial obliteration | Procedure: lumbar sympathetic blockade<br>* Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic<br>|
| Experimental: Group B<br>Distal arterial obliteration | Procedure: lumbar sympathetic blockade<br>* Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic<br>|
| Experimental: Group C<br>Complex arterial obliteration | Procedure: lumbar sympathetic blockade<br>* Skiascopic-guided lumbar sympathetic blockade with the administration of local anesthetic<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 |