High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia (HEAL-SCS)

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Chronic Limb-Threatening Ischemia

Treatments: Procedure: Low-frequency SCS; Procedure: High-frequency SCS

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT05322798

HEAL-SCS

Details and patient eligibility

About

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

Full 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).

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

HF-SCS

Experimental group

Description:

SCS system implantation with high-frequency stimulation availability

Treatment:

Procedure: High-frequency SCS

LF-SCS

Active Comparator group

Description:

Conventional SCS system implantation

Treatment:

Procedure: Low-frequency SCS