diabetic nerve damage diabetic neuropathy
Conditions
Interventions
The treatment with electrostimulation via EVNS is performed using the Releaf
device (Neurecon, Vught, Netherlands). The technique utilizes four independent
channels per leg, each with two pairs of e
Sponsors
Neurecon BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Painful Diabetic Neuropathy refractory for at least 2 pharmacological interventions Being in a mentall and physical state to perform home self-treatment with Releaf for 10 consecutive days or with adequate assistance of care-giver Being in a mental and physical state to understand and complete the research questionnaires
Exclusion criteria
Exclusion criteria: In case of other evident causes for painful neuropathy, significant peripheral arterial disease, active foot ulceration, 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, presence of a medical device based on electrical stimulation, cardiac pacemaker and/or implantable cardioverter defibrillator or any other active implant*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i) 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/SI ii) Successful treatment 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 retrievalof having at least 8/10 adequate treatment sessions iii) Usability, determined by the USER-Experience questionnaire (UEQ), and iv) Number of help requests to service desk | — |
Secondary
| Measure | Time frame |
|---|---|
| i) Neuropathic Pain Symptom Inventory (NPSI) ii) EQ-5D-5L, Quality of Life score | — |
Countries
Netherlands
Outcome results
None listed