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

Study Overview
=================
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).

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

Conditions
-----------------
Chronic Limb-Threatening Ischemia

Intervention / Treatment
-----------------
* Procedure: High-frequency SCS
* Procedure: Low-frequency SCS


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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