Lower Extremity Vasculopathies
Conditions
Interventions
Observation group:None
Sponsors
The First Affiliated Hospital of Xi 'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18–80 years old (inclusive) 2) Participants with confirmed lower extremity vascular diseases, meeting one of the following criteria: With lower extremity arteriosclerotic occlusive disease (predominantly foot lesions) With thromboangiitis obliterans With diabetic foot 3) If complicated with lower extremity ischemic lesions: Participants must be classified as Rutherford Grade 3–5 4) If complicated with lower extremity ischemic lesions: Imaging examination confirming ankle ischemic lesions is mandatory 5) Participants have adequate communication skills and comprehension ability, and can cooperate with the completion of study-related assessments 6) Relevant clinical data are complete (abdominal CT/CTA results are mandatory) 7) Participants agree to participate in this study and have signed the informed consent form
Exclusion criteria
Exclusion criteria: 1) Participants with heart failure (left ventricular ejection fraction(LVEF) <=50%, or New York Heart Association (NYHA) functional class ? or above) 2) Participants requiring unplanned re-interventional surgery within 72 hours after the initial procedure due to disease progression 3) Participants with infectious diseases: Those with local or systemic infections are ineligible for this treatment 4) Participants with coagulation disorders (including hemorrhagic diseases, abnormal coagulation function indicators, etc.) 5) Participants with implanted cardioverter-defibrillators (ICDs), as the treatment may interfere with the normal operation of the device 6) Participants with tumors (including brain tumors, peripheral tumors, and tumors at other sites) 7) Participants with a history of cerebral infarction complicated by severe sequelae (e.g., paralysis) 8) Participants in the active stage of tuberculosis or rheumatic diseases 9) Participants with anatomical factors (e.g., spinal fusion lesions) that hinder puncture and localization, making lumbar sympathetic therapy unfeasible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy rate of lumbar sympathetic radiofrequency ablation (including radiofrequency thermocoagulation or pulsed neurostimulation) for patients with lower extremity vascular disease (defined as a 50% reduction in VAS score from baseline at 6 months post); | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin temperature changes;Ankle-brachial index (ABI/TBI);The rate of toe amputation in subjects at 6 months postoperatively;Walk Impairment Questionnaire (WIQ) score;Assessment of tissue changes in the ischemic area;European Quality of Life Five-Dimensional Health (EQ-5D);Changes of blood vessel imaging before and after revascularization;Dosage and frequency of analgesics;Improvement in sleep;Adverse Events (AEs) During the Follow-up Period;Serious Adverse Events (SAEs);VAS score; | — |
Countries
China
Contacts
Public ContactJun Feng
The First Affiliated Hospital of Xi 'an Jiaotong University
Outcome results
None listed