Investigating whether a device that provides neuromuscular electrical stimulation can improve nerve function in the legs of people with diabetic neuropathy

Not Applicable

• Conditions: Patients with diabetic neuropathy; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN17050221
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-30
• Last Update Posted: 1 April 2024
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified