Diabetic NeuropathiesNCT06670430
Effectiveness of Electrical Stimulation Evaluated Using Digital and Sensorimotor Outcomes in Patients With Sensorimotor Diabetic Peripheral Neuropathy
A study testing experimental group in people with Diabetic Neuropathies, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be carried out on 60 patients both gender male and female with diabetic neuropathy with age55-65 years. The patients will be selected from Elmahmoudia hospital .patients will be randomly assigned to two groups. Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- experimental group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2024to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Diagnosis of diabetes based on World Health Organization (WHO) with ages from 55to 65years 2. BMI> 25kg/m2 3. Clinically diagnosed with diabetic neuropathy. 4. All patients are taking oral hypoglycemic drugs with controlled diabetes mellitus.
- 5. Willingness to comply with the study procedures and interventions. 6. Ability to provide informed consent. 7. presenting with Distal symmetric polyneuropathy (DSPN) based on a score of ≥7 on the validated Michigan Neuropathy Screening Instrument (MNSI) questionnaire.
- 8. exhibiting moderately controlled blood pressure
Who cannot join
- 1. Presence of other significant neurological or musculoskeletal disorders that may confound the assessment of outcomes.
- 2. Severe cognitive impairment or inability to provide informed consent. 3. Any recent surgical procedures or major medical events that could affect the study outcomes.
- 4. Fracture. 5. Heart Failure. 6. Uncooperative patients. 7. Anemic patient. 8. Patients with liver diseases. 9. Smokers Patients. 10. Any cardiac pacemaker, automatic implantable cardioverter defibrillator (AICD), or other implanted electrical device 11. An existing deep vein thrombosis (DVT) 12. Any metal implants 13. Current foot ulceration or other lower limb skin ulcers 14. Any other cause of neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Electrical Stimulation Evaluated Using Digital and Sensorimotor Outcomes in Patients With Diabetic Peripheral Neuropathy
This study will be carried out on 60 patients both gender male and female with diabetic neuropathy with age55-65 years. The patients will be selected from Elmahmoudia hospital .patients will be randomly assigned to two groups.
Read the detailed description
Experimental Group:
This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment.
Control Group:
This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment.
- Conditions
- Diabetic Neuropathies
- Being tested
- experimental group, control group
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupDevice
Also called TENS and NMES
This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment
control groupDevice
Also called placebo TENS and NMES
This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment Receives: Device: experimental group |
| control group | Placebo comparator | This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment Receives: Device: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
nerve conduction velocity
Adhesive patches called surface electrodes are placed on the skin over nerves or muscles at different spots. A very mild electrical impulse is applied via other patches or a handheld stimulator to stimulate the nerve.
The resulting electrical activity of the nerve is recorded by the electrodes. The distance between electrodes and the time it takes for electrical impulses to travel between electrodes are used to measure the speed of the nerve signals. It is normal for several different nerves to be tested.
Measured: 10 weeks
Secondary outcomes (3)
Google Fit
Google Fit is a mobile application developed by Google that focuses on tracking and monitoring physical activity and overall fitness. It is designed to help users lead healthier lifestyles by providing them with tools to set fitness goals, track their activity levels, and monitor their progress over time
Measured: 10 weeks
Manage My Pain
Manage My Pain is a mobile application designed to assist individuals in tracking and managing chronic pain. It provides a comprehensive set of tools for users to monitor pain levels, treatments, and overall well-being. The app allows users to record detailed information about their pain, including intensity, location, triggers, and associated symptoms
Measured: 10 weeks
Electromyography
An EMG evaluates the electrical activity a muscle produces at rest and when it contracts, similar to an EKG of the heart muscle. The doctor places a single, small, Teflon-coated wire pin into selected muscles to be studied. The tip of the pin acts like an antenna, picking up electrical activity from the muscle that can be heard and seen on a screen. You will be asked to tighten (contract) the muscle. Electrical activity is recorded and can be heard as popping and clicking sounds when the muscle is contracting
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start10 Nov 2024
- Primary completion30 Mar 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Abdelaty Marzouk, Cairo University
- Investigators
- nesreen elnahas, phd, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670430
- Sponsor's protocol ID
- P.T.REC/012/005260
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electrical Stimulation Evaluated Using Digital and Sensorimotor Outcomes in Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06670430
- Acronym / sponsor ID
- P.T.REC/012/005260
- Conditions
- Diabetic Neuropathies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 1 Nov 2024 (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.
This study will be carried out on 60 patients both gender male and female with diabetic neuropathy with age55-65 years. The patients will be selected from Elmahmoudia hospital .patients will be randomly assigned to two groups.
Detailed description
Experimental Group:
This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment.
Control Group:
This group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: experimental groupThis group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment |
| control group | Placebo comparator | Device: control groupThis group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Diagnosis of diabetes based on World Health Organization (WHO) with ages from 55to 65years 2. BMI> 25kg/m2 3. Clinically diagnosed with diabetic neuropathy. 4. All patients are taking oral hypoglycemic drugs with controlled diabetes mellitus.
- 5. Willingness to comply with the study procedures and interventions. 6. Ability to provide informed consent. 7. presenting with Distal symmetric polyneuropathy (DSPN) based on a score of ≥7 on the validated Michigan Neuropathy Screening Instrument (MNSI) questionnaire.
- 8. exhibiting moderately controlled blood pressure
Key exclusion criteria (3 listed)
- 1. Presence of other significant neurological or musculoskeletal disorders that may confound the assessment of outcomes.
- 2. Severe cognitive impairment or inability to provide informed consent. 3. Any recent surgical procedures or major medical events that could affect the study outcomes.
- 4. Fracture. 5. Heart Failure. 6. Uncooperative patients. 7. Anemic patient. 8. Patients with liver diseases. 9. Smokers Patients. 10. Any cardiac pacemaker, automatic implantable cardioverter defibrillator (AICD), or other implanted electrical device 11. An existing deep vein thrombosis (DVT) 12. Any metal implants 13. Current foot ulceration or other lower limb skin ulcers 14. Any other cause of neuropathy
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 |
|---|---|---|
| experimental groupAlso: TENS and NMESThis group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive TENS and NMES for 30 minutes 3 days per week,for 10 weeks with medical treatment | Device | experimental group |
| control groupAlso: placebo TENS and NMESThis group will include 30 type II diabetic patients with peripheral neuropathy Patients will receive placebo TENS and NMES for 30-min sessions, 3 days per week, for 10 weeks with medical treatment | Device | control group |
Primary outcome
nerve conduction velocity
Time frame: 10 weeks
Adhesive patches called surface electrodes are placed on the skin over nerves or muscles at different spots. A very mild electrical impulse is applied via other patches or a handheld stimulator to stimulate the nerve. The resulting electrical activity of the nerve is recorded by the electrodes. The distance between electrodes and the time it takes for electrical impulses to travel between electrodes are used to measure the speed of the nerve signals. It is normal for several different nerves to be tested.
3 secondary outcomes
Google Fit
Time frame: 10 weeks
Manage My Pain
Time frame: 10 weeks
Electromyography
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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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.
nesreen elnahas, phd study chair
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group in people with Diabetic Neuropathies, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 17 Aug 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
nerve conduction velocity (time frame: 10 weeks). 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 17 Aug 2026.