Status:
COMPLETED
Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation
Lead Sponsor:
Neurecon BV
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Electrical stimulation with EVNS (Electrical Vasomotor Neuro Stimulation), a methodology used by a specific group of neurostimulators known under various names, has proven its benefit in Painful Diabe...
Eligibility Criteria
Inclusion
- Painful Diabetic Neuropathy (DN4 positive) and insufficiently treated with any combination of 2 of the following drugs: Duloxetine (Cymbalta), venlafaxine (Efexor), ami- or nortriptyline, gabapentine, pregabaline (Lyrica) or the use of carbamazepine or capsaïcine (Qutenza).
- Both feet are present
- Able and willing to complete the treatments in 10 days in a row and completion of questionnaires.
- Being in a mental and physical state to perform home self-treatment with Releaf™ for 10 consecutive days, if necessary with adequate assistance of caregiver.
- Being in a mental and physical state to understand and complete the informed consent form as well as the research questionnaires.
Exclusion
- In case of other evident causes for painful neuropathy,
- Currently participating in another interventional investigational study
- Significant peripheral arterial disease,
- Active foot ulceration or other skin conditions that prevent the application of electrodes on the skin
- Current alcohol or other substance abuse (use of alcohol over the recommended limits of less than 21 units of alcohol per week in men and 14 units in women, Trimbos Intitute),
- Epilepsy,
- Pregnancy,
- Presence of a medical device based on electrical stimulation, cardiac pacemaker and/or implantable cardioverter defibrillator or any other active implant
- Allergy to electrode contact area or to the adhesive substance of the electrode.
Key Trial Info
Start Date :
July 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06524284
Start Date
July 22 2024
End Date
March 30 2025
Last Update
December 9 2025
Active Locations (1)
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1
Neurecon
Vught, Netherlands