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

Conditions: 10034606
diabetic nerve damage
diabetic neuropathy

Registration Number: NL-OMON56887

Lead Sponsor: eurecon BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

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

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*

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>i) The number and severity of reported side-effects of HOME-EVNS, gathered via<br /><br>telephonic consulting on treatment day 1,3 and 8 and via user-initiated<br /><br>incoming calls to the PI/SI<br /><br>ii) Successful treatment defined as cycles with at least 8/10 successful (full<br /><br>35 minutes) treatment sessions, derived from the adherence determined by<br /><br>recording device usage and intensity setting which is downloaded from device<br /><br>after its retrievalof having at least 8/10 adequate treatment sessions<br /><br>iii) Usability, determined by the USER-Experience questionnaire (UEQ), and<br /><br>iv) Number of help requests to service desk</p><br>

Secondary Outcome Measures