High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia
HEAL-SCS
High-frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia (HEAL-SCS): a Randomized Clinical Trial
1 other identifier
interventional
25
1 country
1
Brief Summary
The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedFirst Submitted
Initial submission to the registry
March 30, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedApril 12, 2022
April 1, 2022
1.8 years
March 30, 2022
April 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Visual analog scale (VAS) score
score by visual analog scale (0-10)
12 months
Secondary Outcomes (15)
Visual analog scale (VAS) score
3 months
Walking Impairment Questionnaire (WIQ) - calf pain severity
3 months
Walking Impairment Questionnaire (WIQ) - calf pain severity
12 months
Walking Impairment Questionnaire (WIQ) - walking distance
3 months
Walking Impairment Questionnaire (WIQ) - walking distance
12 months
- +10 more secondary outcomes
Study Arms (2)
HF-SCS
EXPERIMENTALSCS system implantation with high-frequency stimulation availability
LF-SCS
ACTIVE COMPARATORConventional SCS system implantation
Interventions
Continous high-frequency stimulation (frequency - 1kHz, pulse width - 30 µs).
Continuous conventional stimulation (frequency - 30-60 Hz, pulse width - 250-500 µs).
Eligibility Criteria
You may qualify if:
- non-reconstructable critical limb-threatening ischemia (CLTI)
- Fontaine stage IIB-IV
- VAS score 5/10 or more
- succesful SCS trial
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meshalkin National Medical Research Center
Novosibirsk, 630055, Russia
Related Publications (1)
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.
PMID: 36617410DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kiril Orlov, MD, PhD
Meshalkin National Medical Research Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2022
First Posted
April 12, 2022
Study Start
August 12, 2018
Primary Completion
May 30, 2020
Study Completion
May 30, 2021
Last Updated
April 12, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share