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

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Completed

CT.gov ID

NCT05322798

Collaborator

(none)

Enrollment

Location

Arms

33.6

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Limb-Threatening Ischemia	Procedure: High-frequency SCS Procedure: Low-frequency SCS	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 12, 2018

Actual Primary Completion Date :

May 30, 2020

Actual Study Completion Date :

May 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HF-SCS SCS system implantation with high-frequency stimulation availability	Procedure: High-frequency SCS Continous high-frequency stimulation (frequency - 1kHz, pulse width - 30 µs).
Active Comparator: LF-SCS Conventional SCS system implantation	Procedure: Low-frequency SCS Continuous conventional stimulation (frequency - 30-60 Hz, pulse width - 250-500 µs).

Arm

Intervention/Treatment

Experimental: HF-SCS

SCS system implantation with high-frequency stimulation availability

Procedure: High-frequency SCS

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

Active Comparator: LF-SCS

Conventional SCS system implantation

Procedure: Low-frequency SCS

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

Outcome Measures

Primary Outcome Measures

Visual analog scale (VAS) score [12 months]
score by visual analog scale (0-10)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meshalkin National Medical Research Center	Novosibirsk		Russian Federation	630055

Sponsors and Collaborators

Meshalkin Research Institute of Pathology of Circulation

Investigators

Principal Investigator: Kiril Orlov, MD, PhD, Meshalkin National Medical Research Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meshalkin Research Institute of Pathology of Circulation

ClinicalTrials.gov Identifier:

NCT05322798

Other Study ID Numbers:

HEAL-SCS

First Posted:

Apr 12, 2022

Last Update Posted:

Apr 12, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ischemia

Study Results

No Results Posted as of Apr 12, 2022