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

Last updated: October 26, 2023
Sponsor: Europainclinics z.ú.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Occlusions

Treatment

lumbar sympathetic blockade

Clinical Study ID

NCT06111599
4/2023/VUSCH/EK
  • Ages 20-80
  • All Genders

Study Summary

Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Chronic limb-threatening ischemia-Patients with chronic leg pain for at least 6 monthswith intensity (VAS >=5)
  • those who (only if a signature was obtainable), or whose legal guardian,fullyunderstood the clinical trial -details and signed the informed consent form

Exclusion

Exclusion Criteria:

  • Chronic Venous Insufficiency
  • women with positive a pregnancy tests before the trial or who planned to becomepregnant within the following 3 years
  • other patients viewed as inappropriate by the staff
  • disagreement with participation in the study

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: lumbar sympathetic blockade
Phase:
Study Start date:
October 22, 2023
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Europainclinics

    Košice, 04011
    Slovakia

    Active - Recruiting

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