Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation

Inclusion Criteria:

• Painful Diabetic Neuropathy (DN4 positive) and insufficiently treated with anycombination of 2 of the following drugs: Duloxetine (Cymbalta), venlafaxine (Efexor), ami- or nortriptyline, gabapentine, pregabaline (Lyrica) or the use ofcarbamazepine or capsaïcine (Qutenza).

• Both feet are present

• Able and willing to complete the treatments in 10 days in a row and completion ofquestionnaires.

• 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 consentform as well as the research questionnaires.

Exclusion Criteria:

• 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 ofelectrodes on the skin

• Current alcohol or other substance abuse (use of alcohol over the recommended limitsof less than 21 units of alcohol per week in men and 14 units in women, TrimbosIntitute),

• Epilepsy,

• Pregnancy,

• Presence of a medical device based on electrical stimulation, cardiac pacemakerand/or implantable cardioverter defibrillator or any other active implant

• Allergy to electrode contact area or to the adhesive substance of the electrode.