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

NCT06524284 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-09

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Neurecon BV

    lead INDUSTRY

Principal Investigators

  • Ben Imholz, PhD, MD · Neurecon BV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2025-03-04
Completion
2025-03-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524284 on ClinicalTrials.gov