ISRCTN17050221Active, not recruitingUnknown
euroMuscular Electrical Stimulation for the treatment of Diabetic Neuropathy: A multi-centre, double-blind, pilot, randomised, sham-controlled trial (NMES-DN)
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Active, not recruiting
- Sponsor
- Imperial College London
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
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