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

April 10, 2022 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630055
        • Meshalkin National Medical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS) score
Time Frame: 12 months
score by visual analog scale (0-10)
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2018

Primary Completion (Actual)

May 30, 2020

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 10, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 10, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEAL-SCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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