Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRAS ID | Other Identifier | 23712 | |
| NRES REC ID | Other Identifier | 18/NE/0281 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Actegy Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | Standard of Care + Sham Revitive Medic Coach (Sham Neuromuscular Electrical Stimulation Device) for 12 weeks |
|
| Intervention group | Active Comparator | Standard of Care + Revitive Medic Coach (Neuromuscular Electrical Stimulation Device) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome measure: neuropathy symptoms measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part A questionnaire. | Week 6, Week 12, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
INCLUSION CRITERIA
EXCLUSION CRITERIA
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alun H Davies, MA DM DSC FRCS FEBVS | Imperial College London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | W6 8RF | United Kingdom |
Available on request.
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 14, 2025 | Apr 2, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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). |
|
|
| 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) |
| Safety outcome measure: Serious Adverse Events (SAEs) collected and reported via SAE form. | 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. | 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). | 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). | 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). | 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). | 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. | Week 12, Week 26 |
| Secondary outcome measure: blood glucose measured using HbA1c. | Week 12 |
| Secondary outcome measure: mobility and balance measured using validated Berg Balance Scale (BBS). | Week 12, Week 26 |
| Secondary outcome measure: neuropathy signs measured using validated screening questionnaire, Michigan Neuropathy Screening Instrument (MNSI) Part B questionnaire. | Week 12, Week 26 |
| Secondary outcome measure: symptoms measured using Total Symptom Score (TSS). | Week 12 |
| Secondary outcome measure: protected sensation measured using monofilament test. | Week 12, Week 26 |
| Secondary outcome measure: neuropathic pain measured using Neuropathic Pain Symptom Inventory (NPSI). | Week 12, Week 26 |
| Secondary outcome measure: device sensation measured using device sensory threshold and suprathreshold. | Week 12, Week 26 |
| Secondary outcome measure: device experience measured using device experience questionnaire. | Week 12 |
| Secondary outcome measure: device credibility and expectancy measured using modified credibility and expectancy questionnaire. | Baseline |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided