Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation (HOME-EVNS)

Neurecon BV

Status: Enrolling

Conditions: Painful Diabetic Neuropathy

Treatments: Device: Releaf

Study type: Interventional

Funder types: Industry

Identifiers

NCT06524284

HOME-EVNS-01

Details and patient eligibility

About

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 Diabetic Neuropathy (PDN). However, due to the impaired mobility from Diabetic Neuropathy, a part of subjects did not finish the 10 days treatment in the outpatient clinic. Another part of the target group decided not to participate at all for the same reason.

The current study investigates the feasibility, safety and performance of a newly developed EVNS device, called Releaf™, optimised for HOME treatment,

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

EVNS treatment

Experimental group

Description:

EVNS, see intervention

Treatment:

Device: Releaf