Single-Arm, Multicenter, Study to Evaluate Safety and Efficacy of an Ultra-Low Frequency Spinal Cord Stimulator in Subjects with Painful Diabetic Neuropathy
- Conditions
- Painful Diabetic NeuropathyMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12621000741886
- Lead Sponsor
- Presidio Medical AU Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method