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Completed

NCT Number: NCT06524284

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

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,

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Key information

Conditions

Painful Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurecon

Vught, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Releaf

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.

Primary outcomes

  1. Side-effects

    Time frame: Day 1-10

    The number and severity of reported side-effects of HOME-EVNS, gathered via telephonic consulting on treatment day 1,3 and 8 and via user-initiated incoming calls to the PI

  2. Successful treatment cycles

    Time frame: Day 11

    The successful treatment cycles applied at home, defined as cycles with at least 8/10 successful (full 35 minutes) treatment sessions, derived from the adherence determined by recording device usage and intensity setting which is downloaded from device after its retrieval

  3. Reported usability

    Time frame: Day 10

    Usability by the User Questionnaire

  4. Use of helpdesk

    Time frame: Day 1-10

    The number of help requests to service desk.

Secondary outcomes

  1. Neuropathic pain

    Time frame: Before start, after 1 month, after 3 months

    Neuropathic Pain Symptom Inventory (NPSI) filled in by subject

  2. Quality of life score

    Time frame: Before start, after 1 month, after 3 months

    EuroQol 5 Dimension 5 Level (EQ-5D-5L) QoL filled in by subject

Sponsors and collaborators

Lead sponsor

Neurecon BV

Industry

Registry information

Acronym: HOME-EVNS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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