High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia
NCT ID: NCT05322798
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2018-08-12
2021-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HF-SCS
SCS system implantation with high-frequency stimulation availability
High-frequency SCS
Continous high-frequency stimulation (frequency - 1kHz, pulse width - 30 µs).
LF-SCS
Conventional SCS system implantation
Low-frequency SCS
Continuous conventional stimulation (frequency - 30-60 Hz, pulse width - 250-500 µs).
Interventions
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High-frequency SCS
Continous high-frequency stimulation (frequency - 1kHz, pulse width - 30 µs).
Low-frequency SCS
Continuous conventional stimulation (frequency - 30-60 Hz, pulse width - 250-500 µs).
Eligibility Criteria
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Inclusion Criteria
* Fontaine stage IIB-IV
* VAS score 5/10 or more
* succesful SCS trial
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Meshalkin Research Institute of Pathology of Circulation
NETWORK
Responsible Party
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Principal Investigators
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Kiril Orlov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Meshalkin National Medical Research Centre
Locations
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Meshalkin National Medical Research Center
Novosibirsk, , Russia
Countries
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References
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Kilchukov M, Kiselev R, Gorbatykh A, Klinkova A, Murtazin V, Kamenskaya O, Orlov K. High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial. Stereotact Funct Neurosurg. 2023;101(1):1-11. doi: 10.1159/000527309. Epub 2023 Jan 6.
Other Identifiers
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HEAL-SCS
Identifier Type: -
Identifier Source: org_study_id
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