Diabetic Peripheral NeuropathyNMES-DNNCT03767478
Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy
A study testing Revitive Medic Coach (Actegy Ltd) in people with Diabetic Peripheral Neuropathy and Diabetic Neuropathies, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Diabetic Neuropathies, Diabetic Polyneuropathy
- What is being tested?
- Revitive Medic Coach (Actegy Ltd)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Aug 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Electrical Stimulation For The Treatment Of Diabetic Neuropathy: A Multicentre, Double-blind, Pilot, Randomised, Sham-controlled Trial
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
- Being tested
- Revitive Medic Coach (Actegy Ltd), Sham Revitive Medic Coach (Actegy Ltd)
- Keywords
- Neuromuscular electrical stimulation, Nerve conduction
- Medical subject headings
- Diabetic Neuropathies, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revitive Medic Coach (Actegy Ltd)Device
Also called Footplate Neuromuscular Electrical Stimulation 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).
Sham Revitive Medic Coach (Actegy Ltd)Device
Also called Sham Footplate Neuromuscular Electrical Stimulation 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).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Standard of Care + Sham Revitive Medic Coach (Sham Neuromuscular Electrical Stimulation Device) for 12 weeks Receives: Device: Sham Revitive Medic Coach (Actegy Ltd) |
| Intervention group | Active comparator | Standard of Care + Revitive Medic Coach (Neuromuscular Electrical Stimulation Device) for 12 weeks Receives: Device: Revitive Medic Coach (Actegy Ltd) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure: neuropathy symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part A questionnaire.
Measured: Week 6, Week 12, Week 26
Secondary outcomes (21)
Feasibility outcome measure: recruitment rate measured using screening and randomisation logs.
Measured: Pre-screening / Identification, Recruitment and Consent, Baseline
Feasibility outcome measure: participant retention rate measured using randomisation and withdrawal logs.
Measured: Recruitment and Consent, Baseline, Week 12, Week 26
Feasibility outcome measure: adherence to treatment measured using Revitive App and a patient diary.
Measured: Week 12
Safety outcome measure: Adverse Events (AEs) collected and reported via AE form.
Measured: 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.
Measured: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Safety outcome measure: Serious Adverse Events (SAEs) collected and reported via SAE form.
Measured: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Safety outcome measure: Serious Adverse Device Effects (SADEs) collected and reported via SAE form.
Measured: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Secondary outcome measure: sural nerve conductivity measured using a nerve conduction study (central site only).
Nerve conduction parameters include sural nerve conduction velocity (m/s) and SNAP amplitude (µV).
Measured: Week 12, Week 26.
Secondary outcome measure: superficial peroneal nerve conductivity measured using a nerve conduction study (central site only).
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and latency (ms), and SNAP amplitude (μV).
Measured: Week 12, Week 26
Secondary outcome measure: common peroneal nerve conductivity measured using a nerve conduction study (central site only).
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and distal latency (ms), Compound Muscle Action Potential (CMAP) amplitude (mV) and minimum F wave latency (ms).
Measured: Week 12, Week 26
Secondary outcome measure: tibial nerve conductivity measured using a nerve conduction study (central site only).
Nerve conduction parameters include conduction velocity (m/s), calculated using distance and distal latency (ms), Compound Muscle Action Potential (CMAP) amplitude (mV) and minimum F wave latency (ms).
Measured: Week 12, Week 26
Secondary outcome measure: somatosensory nerve fibre function measured using QuantitativeSensory Testing (QST) (central site only).
Somatosensory nerve fibre function will be assessed using the German Research Network on Neuropathic Pain (DFNS) QST protocol. The battery of tests includes measures of cold and warm detection thresholds, paradoxical heat sensations, cold and heat pain thresholds, mechanical detection threshold, mechanical pain threshold, mechanical pain sensitivity, dynamic mechanical allodynia, temporal pain summation, vibration detection threshold and pressure pain threshold.
Measured: Week 12, Week 26
Secondary outcome measure: blood glucose measured using HbA1c.
Measured: Week 12
Secondary outcome measure: mobility and balance measured using validated Berg Balance Scale (BBS).
Measured: Week 12, Week 26
Secondary outcome measure: neuropathy signs measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part B questionnaire.
Measured: Week 12, Week 26
Secondary outcome measure: symptoms measured using Total Symptom Score (TSS).
Measured: Week 12
Secondary outcome measure: protected sensation measured using monofilament test.
Measured: Week 12, Week 26
Secondary outcome measure: neuropathic pain measured using Neuropathic Pain Symptom Inventory (NPSI).
Measured: Week 12, Week 26
Secondary outcome measure: device sensation measured using device sensory threshold and suprathreshold.
Measured: Week 12, Week 26
Secondary outcome measure: device experience measured using device experience questionnaire.
Measured: Week 12
Secondary outcome measure: device credibility and expectancy measured using modified credibility and expectancy questionnaire.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start22 Aug 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Actegy Ltd.
- Responsible party
- Sponsor
- Investigators
- Alun H Davies, MA DM DSC FRCS FEBVS, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767478
- Sponsor's protocol ID
- 18HH4610
- Other IDs
- IRAS ID, NRES REC ID
- Acronym
- NMES-DN
- Status last verified
- Apr 2025
- First submitted
- 27 Nov 2018
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available on request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation For The Treatment Of Diabetic Neuropathy: A Multicentre, Double-blind, Pilot, Randomised, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT03767478
- Acronym / sponsor ID
- NMES-DN / 18HH4610
- Conditions
- Diabetic Peripheral Neuropathy, Diabetic Neuropathies, Diabetic Polyneuropathy, Diabetic Complication
- Keywords
- Neuromuscular electrical stimulation, Nerve conduction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Actegy Ltd.
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Device: Sham Revitive Medic Coach (Actegy Ltd)Standard of Care + Sham Revitive Medic Coach (Sham Neuromuscular Electrical Stimulation Device) for 12 weeks |
| Intervention group | Active comparator | Device: Revitive Medic Coach (Actegy Ltd)Standard of Care + Revitive Medic Coach (Neuromuscular Electrical Stimulation Device) for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- Lacks capacity to provide informed consent
- Pregnant
- Implanted electronic, cardiac or defibrillator device
- Other cause of peripheral neuropathy
- Current foot ulceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revitive Medic Coach (Actegy Ltd)Also: Footplate Neuromuscular Electrical Stimulation DeviceUse 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). | Device | Intervention group |
| Sham Revitive Medic Coach (Actegy Ltd)Also: Sham Footplate Neuromuscular Electrical Stimulation DeviceUse 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). | Device | Control group |
Primary outcome
Primary outcome measure: neuropathy symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part A questionnaire.
Time frame: Week 6, Week 12, Week 26
21 secondary outcomes
Feasibility outcome measure: recruitment rate measured using screening and randomisation logs.
Time frame: Pre-screening / Identification, Recruitment and Consent, Baseline
Feasibility outcome measure: participant retention rate measured using randomisation and withdrawal logs.
Time frame: Recruitment and Consent, Baseline, Week 12, Week 26
Feasibility outcome measure: adherence to treatment measured using Revitive App and a patient diary.
Time frame: Week 12
Safety outcome measure: Adverse Events (AEs) collected and reported via AE form.
Time frame: 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.
Time frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Safety outcome measure: Serious Adverse Events (SAEs) collected and reported via SAE form.
Time frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Safety outcome measure: Serious Adverse Device Effects (SADEs) collected and reported via SAE form.
Time frame: Baseline, Week 3, Week 6, Week 9, Week 12, Week 26 (and any communication in between)
Secondary outcome measure: sural nerve conductivity measured using a nerve conduction study (central site only).
Time frame: Week 12, Week 26.
Secondary outcome measure: superficial peroneal nerve conductivity measured using a nerve conduction study (central site only).
Time frame: Week 12, Week 26
Secondary outcome measure: common peroneal nerve conductivity measured using a nerve conduction study (central site only).
Time frame: Week 12, Week 26
Secondary outcome measure: tibial nerve conductivity measured using a nerve conduction study (central site only).
Time frame: Week 12, Week 26
Secondary outcome measure: somatosensory nerve fibre function measured using QuantitativeSensory Testing (QST) (central site only).
Time frame: Week 12, Week 26
Secondary outcome measure: blood glucose measured using HbA1c.
Time frame: Week 12
Secondary outcome measure: mobility and balance measured using validated Berg Balance Scale (BBS).
Time frame: Week 12, Week 26
Secondary outcome measure: neuropathy signs measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part B questionnaire.
Time frame: Week 12, Week 26
Secondary outcome measure: symptoms measured using Total Symptom Score (TSS).
Time frame: Week 12
Secondary outcome measure: protected sensation measured using monofilament test.
Time frame: Week 12, Week 26
Secondary outcome measure: neuropathic pain measured using Neuropathic Pain Symptom Inventory (NPSI).
Time frame: Week 12, Week 26
Secondary outcome measure: device sensation measured using device sensory threshold and suprathreshold.
Time frame: Week 12, Week 26
Secondary outcome measure: device experience measured using device experience questionnaire.
Time frame: Week 12
Secondary outcome measure: device credibility and expectancy measured using modified credibility and expectancy questionnaire.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Yes. Available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alun H Davies, MA DM DSC FRCS FEBVS study chair
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revitive Medic Coach (Actegy Ltd) in people with Diabetic Peripheral Neuropathy and Diabetic Neuropathies, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome measure: neuropathy symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part A questionnaire. (time frame: Week 6, Week 12, Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.