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

NCT06524284 | Completed

• 1 other identifier: HOME-EVNS-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Side-effects

  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

  Day 1-10

• Successful treatment cycles

  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

  Day 11

• Reported usability

  Usability by the User Questionnaire

  Day 10

• Use of helpdesk

  The number of help requests to service desk.

  Day 1-10

Secondary Outcomes (2)

• Neuropathic pain

  Before start, after 1 month, after 3 months

• Quality of life score

  Before start, after 1 month, after 3 months

Study Arms (1)

EVNS treatment

EXPERIMENTAL

EVNS, see intervention

Device: Releaf

Interventions

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.

EVNS treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurecon BV: lead

Study Sites (1)

Neurecon

Vught, Netherlands

Location

Related Publications (23)

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MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Ben Imholz, PhD, MD

  Neurecon BV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: July 22, 2024
• Primary Completion: March 4, 2025
• Study Completion: March 30, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)