Chronic Limb-Threatening IschemiaHEAL-SCSNCT05322798
High-frequency SCS in Treatment of Chronic Limb-Threatening Ischemia
A study testing High-frequency SCS and Low-frequency SCS in people with Chronic Limb-Threatening Ischemia, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The study of high-frequency spinal cord stimulation (SCS) efficacy in the treatment of chronic limb-threatening ischemia (CLTI) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb-Threatening Ischemia
- What is being tested?
- High-frequency SCS and Low-frequency SCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteRussia
- Study dates
- 12 Aug 2018to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-reconstructable critical limb-threatening ischemia (CLTI)
- Fontaine stage IIB-IV
- VAS score 5/10 or more
- succesful SCS trial
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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).
- Conditions
- Chronic Limb-Threatening Ischemia
- Being tested
- High-frequency SCS, Low-frequency SCS
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency SCSProcedure or surgery
Continous high-frequency stimulation (frequency - 1kHz, pulse width - 30 µs).
Low-frequency SCSProcedure or surgery
Continuous conventional stimulation (frequency - 30-60 Hz, pulse width - 250-500 µs).
| Study group | Role | What they receive |
|---|---|---|
| HF-SCS | Experimental | SCS system implantation with high-frequency stimulation availability Receives: Procedure: High-frequency SCS |
| LF-SCS | Active comparator | Conventional SCS system implantation Receives: Procedure: Low-frequency SCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) score
score by visual analog scale (0-10)
Measured: 12 months
Secondary outcomes (15)
Visual analog scale (VAS) score
score by visual analog scale (0-10)
Measured: 3 months
Walking Impairment Questionnaire (WIQ) - calf pain severity
walking impairment questionnaire score for calf pain severity (0-100)
Measured: 3 months
Walking Impairment Questionnaire (WIQ) - calf pain severity
walking impairment questionnaire score for calf pain severity (0-100)
Measured: 12 months
Walking Impairment Questionnaire (WIQ) - walking distance
walking impairment questionnaire score for walking distance (0-100)
Measured: 3 months
Walking Impairment Questionnaire (WIQ) - walking distance
walking impairment questionnaire score for walking distance (0-100)
Measured: 12 months
Walking Impairment Questionnaire (WIQ) - walking speed
walking impairment questionnaire score for walking speed (0-100)
Measured: 3 months
Walking Impairment Questionnaire (WIQ) - walking speed
walking impairment questionnaire score for walking speed (0-100)
Measured: 12 months
Walking Impairment Questionnaire (WIQ) - stair climbing
walking impairment questionnaire score for stair climbing (0-100)
Measured: 3 months
Walking Impairment Questionnaire (WIQ) - stair climbing
walking impairment questionnaire score for stair climbing (0-100)
Measured: 12 months
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)
Measured: 3 months
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)
Measured: 12 months
SF-36 - mental component summary
quality of life by mental component summary of short form 36 health survey (0-100)
Measured: 3 months
SF-36 - mental component summary
quality of life by mental component summary of short form 36 health survey (0-100)
Measured: 12 months
TcPO2 (rest)
transcutaneous oxygen tension at rest
Measured: 12 months
TcPO2 (orthostatic probe)
transcutaneous oxygen tension during active orthostatic probe
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start12 Aug 2018
- Primary completion30 May 2020
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Limb-Threatening IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Kiril Orlov, MD, PhD, Principal investigator, Meshalkin National Medical Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322798
- Sponsor's protocol ID
- HEAL-SCS
- Acronym
- HEAL-SCS
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kilchukov M, Kiselev R, Gorbatykh A, Klinkova A, Murtazin V, Kamenskaya O, Orlov K. High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial. Stereotact Funct Neurosurg. 2023;101(1):1-11. doi: 10.1159/000527309. Epub 2023 Jan 6.
PubMed 36617410
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia (HEAL-SCS): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05322798
- Acronym / sponsor ID
- HEAL-SCS / HEAL-SCS
- Conditions
- Chronic Limb-Threatening Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 12 Aug 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF-SCS | Experimental | Procedure: High-frequency SCSSCS system implantation with high-frequency stimulation availability |
| LF-SCS | Active comparator | Procedure: Low-frequency SCSConventional SCS system implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non-reconstructable critical limb-threatening ischemia (CLTI)
- Fontaine stage IIB-IV
- VAS score 5/10 or more
- succesful SCS trial
Key exclusion criteria (6 listed)
- intractable acute infection
- allergy to SCS component
- ulcerations larger than 3 cm2
- inadequate patient compliance
- life expectancy less than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-frequency SCSContinous high-frequency stimulation (frequency - 1kHz, pulse width - 30 µs). | Procedure or surgery | HF-SCS |
| Low-frequency SCSContinuous conventional stimulation (frequency - 30-60 Hz, pulse width - 250-500 µs). | Procedure or surgery | LF-SCS |
Primary outcome
Visual analog scale (VAS) score
Time frame: 12 months
score by visual analog scale (0-10)
15 secondary outcomes
Visual analog scale (VAS) score
Time frame: 3 months
Walking Impairment Questionnaire (WIQ) - calf pain severity
Time frame: 3 months
Walking Impairment Questionnaire (WIQ) - calf pain severity
Time frame: 12 months
Walking Impairment Questionnaire (WIQ) - walking distance
Time frame: 3 months
Walking Impairment Questionnaire (WIQ) - walking distance
Time frame: 12 months
Walking Impairment Questionnaire (WIQ) - walking speed
Time frame: 3 months
Walking Impairment Questionnaire (WIQ) - walking speed
Time frame: 12 months
Walking Impairment Questionnaire (WIQ) - stair climbing
Time frame: 3 months
Walking Impairment Questionnaire (WIQ) - stair climbing
Time frame: 12 months
Short form 36 health survey (SF-36) - physical component summary
Time frame: 3 months
Short form 36 health survey (SF-36) - physical component summary
Time frame: 12 months
SF-36 - mental component summary
Time frame: 3 months
SF-36 - mental component summary
Time frame: 12 months
TcPO2 (rest)
Time frame: 12 months
TcPO2 (orthostatic probe)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 36617410Kilchukov M, Kiselev R, Gorbatykh A, Klinkova A, Murtazin V, Kamenskaya O, Orlov K. High-Frequency versus Low-Frequency Spinal Cord Stimulation in Treatment of Chronic Limb-Threatening Ischemia: Short-Term Results of a Randomized Trial. Stereotact Funct Neurosurg. 2023;101(1):1-11. doi: 10.1159/000527309. Epub 2023 Jan 6.
- Individual participant dataSharing planned: No
Related trials for Chronic Limb-Threatening Ischemia
RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiril Orlov, MD, PhD principal investigator
Meshalkin National Medical Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency SCS and Low-frequency SCS in people with Chronic Limb-Threatening Ischemia, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05322798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.