NMES Version 1.0
Research type
Research Study
Full title
Neuromuscular Electrical Stimulation(NMES) for the treatment of Diabetic Peripheral Neuropathy. A Randomised Controlled Trial
IRAS ID
237312
Contact name
Alun Davies
Contact email
Sponsor organisation
Joint Research Compliance Office
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
This is a vascular randomised controlled study that will assess the benefit of using a neuromuscular electrical
stimulation (NMES) device as an adjunct to the local standard care that is available at the study sites, compared to local care alone.
This device is expected to provide further evidence to support the use of NMES in reversing diabetic peripheral neuropathy(DPN). It is also expected that daily home use of NMES may be a practical means to enhance motor performance and plantar sensation in people with DPN.The study will be conducted at the diabetic and vascular clinics at the participating NHS site and is open to all patients with a diagnosis of DPN, meeting specific inclusion and exclusion criteria.
Subject to any patient specific restrictions, all patients will also be provided with best medical therapy (BMT) in order to control for any DPN risk factors.
Treatment will last for 6 months in Group A and 12 months in Group B with follow up conducted 6 months and 12 months thereafter.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0281
Date of REC Opinion
5 Sep 2018
REC opinion
Favourable Opinion