Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy

NCT03767478 | Active Not Recruiting

• 3 other identifiers: 18HH4610IRAS IDNRES REC ID
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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 hypersensitivity in the lower limbs, indicative of sensory nerve loss. Motor neurons can also be affected, leading to muscle weakness and mobility issues, thus preventing patients from engaging in daily routines. Further sequelae include foot ulceration and Charcot neuroarthropathy, which are risk factors for lower limb amputation and mortality. In the United Kingdom, the annual costs of DN alone exceed £300 million, with further complications expected to cost an additional £1 billion. Currently, management strategies for DN focus on prevention and pain management. Neuromuscular electrical stimulation (NMES) is a novel nonpharmacological intervention for people with DN. NMES is the application of electrical impulses which are of sufficiency intensity to improve artificial contraction of the muscle tissue and may help with DN by improving nerve conductivity through direct stimulation of the nerves.

Conditions

Diabetic Peripheral Neuropathy; Diabetic Neuropathies; Diabetic Polyneuropathy; Diabetic Complication

Keywords

Neuromuscular electrical stimulation; Nerve conduction

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure: neuropathy symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part A questionnaire.

  Week 6, Week 12, Week 26

Secondary Outcomes (21)

• Feasibility outcome measure: recruitment rate measured using screening and randomisation logs.

  Pre-screening / Identification, Recruitment and Consent, Baseline

• Feasibility outcome measure: participant retention rate measured using randomisation and withdrawal logs.

  Recruitment and Consent, Baseline, Week 12, Week 26

• Feasibility outcome measure: adherence to treatment measured using Revitive App and a patient diary.

  Week 12

• Safety outcome measure: Adverse Events (AEs) collected and reported via AE form.

  Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)

• Safety outcome measure: Adverse Device Effects (ADEs) collected and reported via AE form.

  Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)

Study Arms (2)

Control group

SHAM COMPARATOR

Standard of Care + Sham Revitive Medic Coach (Sham Neuromuscular Electrical Stimulation Device) for 12 weeks

Device: Sham Revitive Medic Coach (Actegy Ltd)

Intervention group

ACTIVE COMPARATOR

Standard of Care + Revitive Medic Coach (Neuromuscular Electrical Stimulation Device) for 12 weeks

Device: Revitive Medic Coach (Actegy Ltd)

Interventions

Revitive Medic Coach (Actegy Ltd) DEVICE

Use the device for two 30-minute sessions per day, a minimum of five hours per week for 12 weeks at suprathreshold (2 x motor threshold).

Also known as: Footplate Neuromuscular Electrical Stimulation Device

Intervention group

Sham Revitive Medic Coach (Actegy Ltd) DEVICE

Use the device for two 30-minute sessions per day, a minimum of five hours per week for 12 weeks at suprathreshold (2 x motor threshold).

Also known as: Sham Footplate Neuromuscular Electrical Stimulation Device

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Actegy Ltd.: collaborator

Study Sites (1)

Imperial College London

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Complications

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Alun H Davies, MA DM DSC FRCS FEBVS

  Imperial College London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 6, 2018
• Study Start: August 22, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

GB (1)