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,
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Neurecon
Vught, Netherlands
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
Time frame: 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
Time frame: Day 11
Reported usability
Usability by the User Questionnaire
Time frame: Day 10
Use of helpdesk
The number of help requests to service desk.
Time frame: Day 1-10
Neuropathic pain
Neuropathic Pain Symptom Inventory (NPSI) filled in by subject
Time frame: Before start, after 1 month, after 3 months
Quality of life score
EuroQol 5 Dimension 5 Level (EQ-5D-5L) QoL filled in by subject
Time frame: Before start, after 1 month, after 3 months
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