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NCT05322798 Clinical Trial

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

Chronic Limb-Threatening Ischemia Clinical Trial

— HEAL-SCS  

Official title:
High-frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia (HEAL-SCS): a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05322798
Other study ID # HEAL-SCS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 12, 2018
Est. completion date May 30, 2021

Study information
Verified date April 2022
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI)

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).

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date May 30, 2021
Est. primary completion date May 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

  • Chronic Limb-Threatening Ischemia
  • Ischemia

Intervention

Procedure:
• 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).

Locations
Country Name City State
Russian Federation Meshalkin National Medical Research Center Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

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