Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000741886
Ethics application status
Approved
Date submitted
12/05/2021
Date registered
11/06/2021
Date last updated
11/06/2021
Date data sharing statement initially provided
11/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Single-Arm, Multicenter, Study to Evaluate Safety and Efficacy of an Ultra-Low Frequency Spinal Cord Stimulator in Subjects with Painful Diabetic Neuropathy
Scientific title
Single-Arm, Multicenter, Study to Evaluate Safety and Efficacy of an Ultra-Low Frequency Spinal Cord Stimulator in Subjects with Painful Diabetic Neuropathy
Secondary ID [1] 303799 0
PMH-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Painful Diabetic Neuropathy 321307 0
Condition category
Condition code
Metabolic and Endocrine 319093 319093 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to evaluate the safety and effectiveness of the Presidio Medical ULF-SCS over a 15-day period in subjects with Painful Diabetic Neuropathy.

The Presidio Medical ULF-SCS system is a form of spinal cord stimulation (SCS) that uses ultra low frequency (less than 1Hz) electrical currents to the epidural space to modulate the conduction of nerve pain.

The participants will have epidural leads implanted for up to 15 days in an operating room setting. It will be performed by a pain management specialist surgeon in a day surgery setting under general or sedation anaesthesia with a procedure lasting approximately 1 hr. The trial system consists of epidural leads (implanted in the T8-T10 region), lead adapters, an external pulse generator (EPG), surface electrodes, and a programming application. The participant will wear the EPG on a hip belt and will have control to continue, pause or stop stimulation.

The participant will return to the clinic at days 1, 3 and 7 to adjust their stimulation. The device is anticipated to provide near-continuous stimulation throughout the trial though it is able to be paused or stopped by the participant. The entire system will be removed at Day 15. The usage data from the device will be downloaded at every clinic visit to assess for total run time and device performance.

The stimulation may be paused in the following instances: taking a sponge bath or driving.
Intervention code [1] 320103 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Active

Outcomes
Primary outcome [1] 326985 0
The primary effectiveness endpoint will be the percentage of subjects who experience over 50% pain relief during the duration of the trial compared to baseline.
Timepoint [1] 326985 0
Data will be collected at all participant visits including Day 0 (implant procedure) through Day 23 (study exit).
Secondary outcome [1] 393345 0
The secondary endpoint is the proportion of subjects with a 50% or greater reduction in VAS.
Timepoint [1] 393345 0
Timepoints will be Days 3, 7, and 15.

Eligibility
Key inclusion criteria
1. Have been diagnosed with lower extremity painful diabetic neuropathy for a minimum of 3 months
2. VAS greater than or equal to 50mm for the past week
3. Have stable neurological status
4. Eighteen (18) years of age or older
5. Literate, able to speak English and able to complete questionnaires independently
6. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
7. Are currently receiving optimal medical management and considered medically stable as judged by investigator
8. Ability to independently change AA batteries and operate EPG.
9. Able to comply with study requirements and attend all scheduled visits
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a diagnosis of a lower limb mononeuropathy, have had a lower limb amputation, or have ulcers of the lower limbs
2. If female and sexually active, and the subject is not using a reliable form of birth control, is not surgically sterile or at least two years post-menopausal, the subject shall be excluded, as confirmed by the investigator
3. A Hemoglobin A1C (HgB A1C) level that is greater than (>) 9%
4. Body Mass Index (BMI) score that is > 40
5. Diagnosis of Fibromyalgia
6. VAS greater than or equal to 30mm in the legs or trunk that would make accurate assessment of change difficult, as determined by investigator.
7. Severe cognitive impairment as determined by investigator
8. Average total daily morphine equivalent dose (MED) of >100 mg
9. A psychological assessment will be performed at Baseline to exclude any diagnosis of active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance, intervention and/or ability to evaluate treatment outcome as assessed by a clinical psychologist or psychiatrist.
10. Spinal stenosis or other structural spinal abnormality observed on MRI (or CT scan) that would make lead placement unsafe or untowardly difficult as determined by investigator
11. Currently taking anticoagulants including Warfarin, Heparin, Low Molecular Weight Heparin, Factor Xa inhibitors, GPIIb/IIIa inhibitors, thienopyridine inhibitors, direct thrombin inhibitors, or any other anticoagulant that is a contraindication to epidural lead placement within 1 week of the Screening Visit
12. Current coagulopathy, thrombocytopenia or bleeding diathesis (confirmed by clinical history and, if clinically indicated, by coagulation screening)
13. Cardiac demand pacemaker, implanted defibrillator or another implanted electronic device
14. A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.)
15. Known hypersensitivity to any of the procedural agents or materials in the study device that is inserted into the subject
16. Previous use of spinal cord stimulation or comparable therapy
17. A known need for an MRI or surgery between the screening visit through the end of the study.
18. Any experimental drug or device used within 30 days prior to the Screening Visit or during the course of the clinical trial
19. Subjects who are involved in ongoing or closed (within 30 days of the screening visit) litigation related to their pain condition

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The assessment of effectiveness will be based on reduction in pain in the treatment area as measured by VAS as compared to baseline. Changes from baseline at all follow ups will be assessed using a repeated measures ANOVA or Friedman’s test, as appropriate. Post-hoc pairwise comparisons will be performed using Turkey’s HSD or Wilcoxon signed-rank test, as appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/05/2021
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
10
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment postcode(s) [1] 33569 0
5035 - Ashford
Recruitment postcode(s) [2] 33570 0
2292 - Broadmeadow

Funding & Sponsors
Funding source category [1] 308199 0
Commercial sector/Industry
Name [1] 308199 0
Presidio Medical AU Pty Ltd
Country [1] 308199 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Presidio Medical AU Pty Ltd
Address
58 Gipps Street, Collingwood VIC 3066
Country
Australia
Secondary sponsor category [1] 308980 0
None
Name [1] 308980 0
Address [1] 308980 0
Country [1] 308980 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308180 0
Bellberry HREC
Ethics committee address [1] 308180 0
123 Glen Osmond Street, Eastwood SA 5063
Ethics committee country [1] 308180 0
Australia
Date submitted for ethics approval [1] 308180 0
02/03/2021
Approval date [1] 308180 0
23/04/2021
Ethics approval number [1] 308180 0
2021-02-189

Summary
Brief summary
This study seeks to evaluate the safety and effectiveness of an experimental type of spinal cord stimulator. The device is not yet approved for use in Australia for the treatment of Painful Diabetic Neuropathy. The experimental device is used for 15 days and is then removed. The experimental stimulator delivers a different wavelength that other traditional spinal cord stimulators and it may help to alleviate pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109826 0
Dr Willem Volschenk
Address 109826 0
Genesis Research Services, 220 Denison St, Broadmeadow NSW 2292
Country 109826 0
Australia
Phone 109826 0
+61249851860
Fax 109826 0
Email 109826 0
[email protected]
Contact person for public queries
Name 109827 0
Dr Willem Volschenk
Address 109827 0
Genesis Research Services, 220 Denison St, Broadmeadow NSW 2292
Country 109827 0
Australia
Phone 109827 0
+61249851860
Fax 109827 0
Email 109827 0
[email protected]
Contact person for scientific queries
Name 109828 0
Dr Andrew Sullivan
Address 109828 0
Presidio Medical AU Pty Ltd 58 Gipps Street Collingwood VIC 3066
Country 109828 0
Australia
Phone 109828 0
+61448673393
Fax 109828 0
Email 109828 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be aggregated.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.