Thermovision-controlled lumbar sympathetic blockade for treating chronic limb-threatening ischemia
Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment
This study is testing a new way to relieve pain and improve blood flow in people with severe leg circulation problems by using a special guided procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | EPC Education s.r.o. Academic / other |
| Locations | 1 site (Košice) |
| Trial ID | NCT06111599 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of thermovision-controlled lumbar sympathetic blockade as a treatment for chronic limb-threatening ischemia (CLTI), a severe condition characterized by critical limb ischemia. The approach involves a minimally invasive, fluoroscopy-guided procedure aimed at alleviating pain and improving blood flow in patients suffering from this debilitating condition. Participants will be monitored for tissue oxygen levels to assess the effectiveness of the intervention. The study aims to provide a novel therapeutic option for patients who have not responded to conventional treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are patients experiencing chronic leg pain due to chronic limb-threatening ischemia for at least six months.
Not a fit: Patients with chronic venous insufficiency or those who are pregnant or planning to become pregnant within three years may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and quality of life for patients with chronic limb-threatening ischemia.
How similar studies have performed: While the results of traditional surgical lumbar sympathectomy have been unclear, this novel approach using thermal vision control has not been extensively tested, making it a potentially innovative intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Košice
- Europainclinics — Košice, Slovakia (Recruiting)
Study contacts
- Study coordinator: Ladislav Kočan, MD, PhD, FIPP
- Email: kocanladislav@gmail.com
- Phone: +421907440250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.