High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia

Not Applicable

Completed

• Conditions: Chronic Limb-Threatening Ischemia

• Registration Number: NCT05322798
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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).

Study Timeline

• Study Start: 2018-08-12
• Primary Completion: 2020-05-30
• Study Completion: 2021-05-30
• Study First Submitted: 2022-03-30
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-10
• Last Update Submitted: 2022-04-10
• Study First Posted: 2022-04-12
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS) score	12 months	score by visual analog scale (0-10)

Secondary Outcome Measures

Name	Time	Method
TcPO2 (rest)	12 months	transcutaneous oxygen tension at rest
Walking Impairment Questionnaire (WIQ) - walking distance	12 months	walking impairment questionnaire score for walking distance (0-100)
Walking Impairment Questionnaire (WIQ) - walking speed	12 months	walking impairment questionnaire score for walking speed (0-100)
SF-36 - mental component summary	12 months	quality of life by mental component summary of short form 36 health survey (0-100)
Visual analog scale (VAS) score	3 months	score by visual analog scale (0-10)
Walking Impairment Questionnaire (WIQ) - calf pain severity	12 months	walking impairment questionnaire score for calf pain severity (0-100)
Walking Impairment Questionnaire (WIQ) - stair climbing	12 months	walking impairment questionnaire score for stair climbing (0-100)
Short form 36 health survey (SF-36) - physical component summary	12 months	quality of life by physical component summary of short form 36 health survey (0-100)
TcPO2 (orthostatic probe)	12 months	transcutaneous oxygen tension during active orthostatic probe

Trial Locations

Locations (1)

Meshalkin National Medical Research Center; 🇷🇺 Novosibirsk, Russian Federation