Status:
ACTIVE_NOT_RECRUITING
Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Actegy Ltd.
Conditions:
Diabetic Peripheral Neuropathy
Diabetic Neuropathies
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Diabetic neuropathy (DN) is the most common complication of diabetes, affecting almost 50% of people with diabetes over the course of their lives. Symptoms vary from numbness to burning, aching and hy...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Aged ≥18 (no upper limit)
- Diagnosis of type 1 or type 2 diabetes based on World Health Organisation (WHO) definition
- Diagnosis of diabetic neuropathy based on validated screening questionnaire Michigan Neuropathy Screening Instrument score of ≥4
- Access to internet at home to use the Revitive App (study smartphones will be provided)
- EXCLUSION CRITERIA
- Lacks capacity to provide informed consent
- Pregnant
- Implanted electronic, cardiac or defibrillator device
- Other cause of peripheral neuropathy
- Current foot ulceration
- Severe vascular disease requiring invasive intervention
- Being treated for, or have the symptoms of, an existing deep vein thrombosis (DVT)
- Used a neuromuscular electrical stimulation (NMES) device within 1 year of randomisation
Exclusion
Key Trial Info
Start Date :
August 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03767478
Start Date
August 22 2023
End Date
June 30 2025
Last Update
April 9 2025
Active Locations (1)
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1
Imperial College London
London, United Kingdom, W6 8RF