Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-22

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Peripheral Neuropathy Diabetic Neuropathies Diabetic Polyneuropathy Diabetic Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group

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

Group Type SHAM_COMPARATOR

Sham Revitive Medic Coach (Actegy Ltd)

Intervention Type 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).

Intervention group

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

Group Type ACTIVE_COMPARATOR

Revitive Medic Coach (Actegy Ltd)

Intervention Type 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).

Interventions

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Revitive Medic Coach (Actegy Ltd)

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).

Intervention Type DEVICE

Sham Revitive Medic Coach (Actegy Ltd)

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).

Intervention Type DEVICE

Other Intervention Names

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Footplate Neuromuscular Electrical Stimulation Device Sham Footplate Neuromuscular Electrical Stimulation Device

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No