Status:
COMPLETED
High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Chronic Limb-Threatening Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI)
Detailed Description
Open-label, parallel-group, randomized study with a 1:1 allocation ratio to check the hypothesis of whether high-frequency-SCS (HF-SCS) is better than conventional low-frequency (LF-SCS) for pain reli...
Eligibility Criteria
Inclusion
- non-reconstructable critical limb-threatening ischemia (CLTI)
- Fontaine stage IIB-IV
- VAS score 5/10 or more
- succesful SCS trial
Exclusion
- intractable acute infection
- allergy to SCS component
- ulcerations larger than 3 cm2
- inadequate patient compliance
- life expectancy less than 12 months
- patient refuse to participate in any stage of the study
Key Trial Info
Start Date :
August 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05322798
Start Date
August 12 2018
End Date
May 30 2021
Last Update
April 12 2022
Active Locations (1)
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1
Meshalkin National Medical Research Center
Novosibirsk, Russia, 630055