NCT05322798
Completed
Not Applicable
High-frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia (HEAL-SCS): a Randomized Clinical Trial
Meshalkin Research Institute of Pathology of Circulation1 site in 1 country25 target enrollmentAugust 12, 2018
ConditionsChronic Limb-Threatening Ischemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Limb-Threatening Ischemia
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Visual analog scale (VAS) score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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 relief in patients with chronic limb-threatening ischemia (CLTI).
Investigators
Eligibility Criteria
Inclusion Criteria
- •non-reconstructable critical limb-threatening ischemia (CLTI)
- •Fontaine stage IIB-IV
- •VAS score 5/10 or more
- •succesful SCS trial
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Visual analog scale (VAS) score
Time Frame: 12 months
score by visual analog scale (0-10)
Secondary Outcomes
- TcPO2 (rest)(12 months)
- Walking Impairment Questionnaire (WIQ) - walking distance(12 months)
- Walking Impairment Questionnaire (WIQ) - walking speed(12 months)
- SF-36 - mental component summary(12 months)
- Visual analog scale (VAS) score(3 months)
- Walking Impairment Questionnaire (WIQ) - calf pain severity(12 months)
- Walking Impairment Questionnaire (WIQ) - stair climbing(12 months)
- Short form 36 health survey (SF-36) - physical component summary(12 months)
- TcPO2 (orthostatic probe)(12 months)
Study Sites (1)
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