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

NCT ID: NCT06524284

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-22
• Study Completion Date: 2025-03-30

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 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,

Conditions

Painful Diabetic Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EVNS treatment

EVNS, see intervention

Group Type: EXPERIMENTAL

Releaf

Intervention Type: DEVICE

10 days/35 minutes per day EVNS (non-invasive electrostimulation) treatment on lower legs and feet by the subject or its caregiver after instruction by the podiatrist.

Interventions

Releaf

10 days/35 minutes per day EVNS (non-invasive electrostimulation) treatment on lower legs and feet by the subject or its caregiver after instruction by the podiatrist.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurecon BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ben Imholz, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Neurecon BV

Locations

Neurecon

Vught, , Netherlands

Countries

Netherlands

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Other Identifiers

HOME-EVNS-01

Identifier Type: -

Identifier Source: org_study_id