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

Primary Purpose

Chronic Limb-Threatening Ischemia

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
High-frequency SCS
Low-frequency SCS
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Limb-Threatening Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Meshalkin National Medical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HF-SCS

LF-SCS

Arm Description

SCS system implantation with high-frequency stimulation availability

Conventional SCS system implantation

Outcomes

Primary Outcome Measures

Visual analog scale (VAS) score
score by visual analog scale (0-10)

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2022
Last Updated
April 10, 2022
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT05322798
Brief Title
High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia
Acronym
HEAL-SCS
Official Title
High-frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia (HEAL-SCS): a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2018 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Limb-Threatening Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HF-SCS
Arm Type
Experimental
Arm Description
SCS system implantation with high-frequency stimulation availability
Arm Title
LF-SCS
Arm Type
Active Comparator
Arm Description
Conventional SCS system implantation
Intervention Type
Procedure
Intervention Name(s)
High-frequency SCS
Intervention Description
Continous high-frequency stimulation (frequency - 1kHz, pulse width - 30 µs).
Intervention Type
Procedure
Intervention Name(s)
Low-frequency SCS
Intervention Description
Continuous conventional stimulation (frequency - 30-60 Hz, pulse width - 250-500 µs).
Primary Outcome Measure Information:
Title
Visual analog scale (VAS) score
Description
score by visual analog scale (0-10)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS) score
Description
score by visual analog scale (0-10)
Time Frame
3 months
Title
Walking Impairment Questionnaire (WIQ) - calf pain severity
Description
walking impairment questionnaire score for calf pain severity (0-100)
Time Frame
3 months
Title
Walking Impairment Questionnaire (WIQ) - calf pain severity
Description
walking impairment questionnaire score for calf pain severity (0-100)
Time Frame
12 months
Title
Walking Impairment Questionnaire (WIQ) - walking distance
Description
walking impairment questionnaire score for walking distance (0-100)
Time Frame
3 months
Title
Walking Impairment Questionnaire (WIQ) - walking distance
Description
walking impairment questionnaire score for walking distance (0-100)
Time Frame
12 months
Title
Walking Impairment Questionnaire (WIQ) - walking speed
Description
walking impairment questionnaire score for walking speed (0-100)
Time Frame
3 months
Title
Walking Impairment Questionnaire (WIQ) - walking speed
Description
walking impairment questionnaire score for walking speed (0-100)
Time Frame
12 months
Title
Walking Impairment Questionnaire (WIQ) - stair climbing
Description
walking impairment questionnaire score for stair climbing (0-100)
Time Frame
3 months
Title
Walking Impairment Questionnaire (WIQ) - stair climbing
Description
walking impairment questionnaire score for stair climbing (0-100)
Time Frame
12 months
Title
Short form 36 health survey (SF-36) - physical component summary
Description
quality of life by physical component summary of short form 36 health survey (0-100)
Time Frame
3 months
Title
Short form 36 health survey (SF-36) - physical component summary
Description
quality of life by physical component summary of short form 36 health survey (0-100)
Time Frame
12 months
Title
SF-36 - mental component summary
Description
quality of life by mental component summary of short form 36 health survey (0-100)
Time Frame
3 months
Title
SF-36 - mental component summary
Description
quality of life by mental component summary of short form 36 health survey (0-100)
Time Frame
12 months
Title
TcPO2 (rest)
Description
transcutaneous oxygen tension at rest
Time Frame
12 months
Title
TcPO2 (orthostatic probe)
Description
transcutaneous oxygen tension during active orthostatic probe
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiril Orlov, MD, PhD
Organizational Affiliation
Meshalkin National Medical Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meshalkin National Medical Research Center
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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