ISRCTN17050221
Active, Not Recruiting
N/A
euroMuscular Electrical Stimulation for the treatment of Diabetic Neuropathy: A multi-centre, double-blind, pilot, randomised, sham-controlled trial (NMES-DN)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Patients with diabetic neuropathy
- Sponsor
- Imperial College London
- Enrollment
- 100
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged \=18 (no upper limit)
- •2\. Diagnosis of type 1 or type 2 diabetes based on World Health Organisation (WHO) definition
- •3\. Diagnosis of diabetic neuropathy based on:
- •3\.1\. Symptoms of diabetic neuropathy
- •3\.2\. Validated screening questionnaire Michigan Neuropathy Screening Instrument score of \=4
- •3\.3\. Nerve conduction study of at least one lower limb must have a sural sensory nerve action potential (SNAP) amplitude of \<6 µV or absent
- •4\. Access to the internet at home to use the Revitive App (study smartphones will be provided)
- •5\. Personal mobile phone to receive text messages
Exclusion Criteria
- •1\. Lacks the capacity to provide informed consent
- •2\. Pregnant
- •3\. Implanted electronic, cardiac or defibrillator device
- •4\. Other causes of peripheral neuropathy (e.g. excessive drinking, low levels of vitamin B12 or other vitamins, syphilis, HIV, underactive thyroid gland)
- •5\. Current foot ulceration
- •6\. Severe vascular disease requiring invasive intervention
- •7\. Being treated for, or having the symptoms of, an existing deep vein thrombosis (DVT)
- •8\. Used a neuromuscular electrical stimulation (NMES) device within 1 year of randomisation
Outcomes
Primary Outcomes
Not specified
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