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About the study

PDPN affects 25% of people with diabetes and 70% of sufferers have moderate-to-severe pain. PDPN is associated with sleep disruption, poor quality of life (QoL), unemployment & depression

Aim of the study

The study aims to evaluate the efficacy of FREMS (Frequency Rhythmic Electrical Modulated System) in patients with painful diabetic peripheral neuropathy (PDPN, painful feet from nerve damages caused by diabetes) who have not responded to the NICE (National Institute for Health and Care Excellence) recommended treatments. FREMS delivers electrical pulses via stickers that are placed on the feet and legs; these pulses can reduce the pain in patients with PDPN.

Current enrolment curve

Recruitment target: 356

Locations

Study team

Dr Bernhard Frank

Chief Investigator

Consultant in Pain Medicine, Walton Centre NHS Foundation Trust. Honorary Clinical Senior Lecturer, University of Liverpool

Dr Abd Tahrani

Joint Lead Applicant

Honorary Professor of Medicine at the University of Birmingham and an Honorary Consultant in Endocrinology, Diabetes and Weight Management at the University Hospitals of Birmingham NHS Foundation Trust.

Sam Hopkins

Senior Trial Manager

Sam is a senior trial manager at Birmingham Clinical Trials Unit based at the University of Birmingham. She has over 13 years of experience working on clinical trials, in a range of different specialities in both an NHS and academic setting.

Information about the study

Treatments

FREMS and TENS - both give electrical pulses delivered through stickers on the skin.

Study Duration

3 years, 6 months

Study Funders

This study is funded by the NIHR HTA Programme project reference 133599. The study is sponsored by The University of Birmingham.

Study Design

A randomised controlled trial to assess the efficacy of FREMS in patients with PDPN who have significant pain despite trying the NICE recommended treatments.

Participant Population and Sample Size

356 adults with PDPN for ≥3 months with significant pain (mean pain Numerical Rating Scale [NRS] ≥4 for a week prior to randomisation) despite trying ≥2 different classes of PDPN medications.

Outcome Measures

The main study outcome is pain severity collected by text message from the participants. Other outcomes include QoL, sleep quality, medication changes & value for money.