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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05322798
Acronym
HEAL-SCS
Enrollment
25
Registered
2022-04-12
Start date
2018-08-12
Completion date
2021-05-30
Last updated
2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Limb-Threatening Ischemia

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).

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).

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analog scale (VAS) score12 monthsscore by visual analog scale (0-10)

Secondary

MeasureTime frameDescription
Walking Impairment Questionnaire (WIQ) - walking speed3 monthswalking impairment questionnaire score for walking speed (0-100)
Visual analog scale (VAS) score3 monthsscore by visual analog scale (0-10)
Walking Impairment Questionnaire (WIQ) - calf pain severity3 monthswalking impairment questionnaire score for calf pain severity (0-100)
Walking Impairment Questionnaire (WIQ) - stair climbing3 monthswalking impairment questionnaire score for stair climbing (0-100)
Walking Impairment Questionnaire (WIQ) - walking distance3 monthswalking impairment questionnaire score for walking distance (0-100)
SF-36 - mental component summary3 monthsquality of life by mental component summary of short form 36 health survey (0-100)
TcPO2 (rest)12 monthstranscutaneous oxygen tension at rest
TcPO2 (orthostatic probe)12 monthstranscutaneous oxygen tension during active orthostatic probe
Short form 36 health survey (SF-36) - physical component summary3 monthsquality of life by physical component summary of short form 36 health survey (0-100)

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026