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Completed

NCT Number: NCT05322798

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

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

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Key information

Conditions

Chronic Limb-Threatening Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meshalkin National Medical Research Center

Novosibirsk, 630055, Russia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-frequency SCS

Procedure

Continous high-frequency stimulation (frequency - 1kHz, pulse width - 30 µs).

Low-frequency SCS

Procedure

Continuous conventional stimulation (frequency - 30-60 Hz, pulse width - 250-500 µs).

Primary outcomes

  1. Visual analog scale (VAS) score

    Time frame: 12 months

    score by visual analog scale (0-10)

Secondary outcomes

  1. Visual analog scale (VAS) score

    Time frame: 3 months

    score by visual analog scale (0-10)

  2. Walking Impairment Questionnaire (WIQ) - calf pain severity

    Time frame: 3 months

    walking impairment questionnaire score for calf pain severity (0-100)

  3. Walking Impairment Questionnaire (WIQ) - calf pain severity

    Time frame: 12 months

    walking impairment questionnaire score for calf pain severity (0-100)

  4. Walking Impairment Questionnaire (WIQ) - walking distance

    Time frame: 3 months

    walking impairment questionnaire score for walking distance (0-100)

  5. Walking Impairment Questionnaire (WIQ) - walking distance

    Time frame: 12 months

    walking impairment questionnaire score for walking distance (0-100)

  6. Walking Impairment Questionnaire (WIQ) - walking speed

    Time frame: 3 months

    walking impairment questionnaire score for walking speed (0-100)

  7. Walking Impairment Questionnaire (WIQ) - walking speed

    Time frame: 12 months

    walking impairment questionnaire score for walking speed (0-100)

  8. Walking Impairment Questionnaire (WIQ) - stair climbing

    Time frame: 3 months

    walking impairment questionnaire score for stair climbing (0-100)

  9. Walking Impairment Questionnaire (WIQ) - stair climbing

    Time frame: 12 months

    walking impairment questionnaire score for stair climbing (0-100)

  10. Short form 36 health survey (SF-36) - physical component summary

    Time frame: 3 months

    quality of life by physical component summary of short form 36 health survey (0-100)

  11. Short form 36 health survey (SF-36) - physical component summary

    Time frame: 12 months

    quality of life by physical component summary of short form 36 health survey (0-100)

  12. SF-36 - mental component summary

    Time frame: 3 months

    quality of life by mental component summary of short form 36 health survey (0-100)

  13. SF-36 - mental component summary

    Time frame: 12 months

    quality of life by mental component summary of short form 36 health survey (0-100)

  14. TcPO2 (rest)

    Time frame: 12 months

    transcutaneous oxygen tension at rest

  15. TcPO2 (orthostatic probe)

    Time frame: 12 months

    transcutaneous oxygen tension during active orthostatic probe

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Acronym: HEAL-SCS

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 12, 2022
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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