NCT06524284

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Neurecon BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-07-22
• Primary completion: 2025-03-04
• Completion: 2025-03-30
• First posted: 2024-07-29
• Last updated: 2025-12-09

Locations

1 site across 1 country: Netherlands