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CompletedNCT05322798HEAL-SCSUpdated Apr 12, 2022

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

An interventional study of High-frequency SCS and Low-frequency SCS in Chronic Limb-Threatening Ischemia, sponsored by Meshalkin Research Institute of Pathology of Circulation. Completed at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by Meshalkin Research Institute of Pathology of Circulation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Aug 2018, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Chronic Limb-Threatening Ischemia
03

In context

Chronic Limb-Threatening Ischemia

348 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 70 are open to participants now.

This study's enrollment of 25 is below the median of 43 across 236 interventional studies indexed under Chronic Limb-Threatening Ischemia.

Browse Chronic Limb-Threatening Ischemia studies →

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 118 studies on the registry; 8 are open to participants now.

Browse Meshalkin Research Institute of Pathology of Circulation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • non-reconstructable critical limb-threatening ischemia (CLTI)
  • Fontaine stage IIB-IV
  • VAS score 5/10 or more
  • succesful SCS trial

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    HF-SCS

    SCS system implantation with high-frequency stimulation availability

    Procedure: High-frequency SCS

  • Active comparator
    LF-SCS

    Conventional SCS system implantation

    Procedure: Low-frequency SCS

Interventions

  • ProcedureHigh-frequency SCS

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

  • ProcedureLow-frequency SCS

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

06

What researchers measure

Primary outcomes

  1. Visual analog scale (VAS) score

    score by visual analog scale (0-10)

    Time frame: 12 months

Secondary outcomes

  1. Visual analog scale (VAS) score

    score by visual analog scale (0-10)

    Time frame: 3 months

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

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

    Time frame: 3 months

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

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

    Time frame: 12 months

  4. Walking Impairment Questionnaire (WIQ) - walking distance

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

    Time frame: 3 months

  5. Walking Impairment Questionnaire (WIQ) - walking distance

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

    Time frame: 12 months

  6. Walking Impairment Questionnaire (WIQ) - walking speed

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

    Time frame: 3 months

  7. Walking Impairment Questionnaire (WIQ) - walking speed

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

    Time frame: 12 months

  8. Walking Impairment Questionnaire (WIQ) - stair climbing

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

    Time frame: 3 months

  9. Walking Impairment Questionnaire (WIQ) - stair climbing

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

    Time frame: 12 months

  10. 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)

    Time frame: 3 months

  11. 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)

    Time frame: 12 months

  12. SF-36 - mental component summary

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

    Time frame: 3 months

  13. SF-36 - mental component summary

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

    Time frame: 12 months

  14. TcPO2 (rest)

    transcutaneous oxygen tension at rest

    Time frame: 12 months

  15. TcPO2 (orthostatic probe)

    transcutaneous oxygen tension during active orthostatic probe

    Time frame: 12 months

07

Study locations

1 site
  • Meshalkin National Medical Research Center
    Novosibirsk, 630055, Russia
08

References and documents

Publications

  • 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. PubMed 36617410 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in May 2020, 21 months.

Of 67 interventional studies with no phase under Chronic Limb-Threatening Ischemia, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 62. This study's 21 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2022
First posted
Apr 12, 2022
StartActual
Aug 12, 2018
Primary completionActual
May 30, 2020
CompletionActual
May 30, 2021
Last update
Apr 12, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05322798
Lead sponsor
Meshalkin Research Institute of Pathology of Circulation
Responsible party
Sponsor
First posted
Apr 12, 2022
Start date
Aug 12, 2018
Primary completion
May 30, 2020
Completion
May 30, 2021
Last update
Apr 12, 2022

Study contacts

Kiril Orlov, MD, PhD
principal investigator · Meshalkin National Medical Research Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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