Diabetic Neuropathy PeripheralPhase 3NCT04253860
Effect of Transcutaneous Electrical Nerve Stimulation in Diabetic Neuropathy
A Phase 3 study testing Transcutaneous electrical neurostimulation in people with Diabetic Neuropathy Peripheral, run by Centro Universitario de Tonalá at 1 site in Mexico.
Trial summary
Double-blind, randomized, placebo-controlled, clinical trial. Patients with diabetic neuropathy will be randomly assigned to treatment with either TENS or TENS sham three times a week during 90 days. Clinical determinations are: pain, levesls of TNF-alpha, IL-6 and RPC-us Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetic Neuropathy Peripheral
- What is being tested?
- Transcutaneous electrical neurostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2019to 30 Jul 2021
- Phase
- Phase 3
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic of type 2 diabetes > 10 years
- Diagnostic of peripheral diabetic neuropathy less than 5 years
- HbA1C > 6.5 and < 9%
- Plasmatic glucose >140 mg/dL and lees than 350 mg/dL
- Informed consent signed
Who cannot join
- Use of implanted pacemaker or heart defibrillator
- Implanted brain stimulator
- History of alcohol abuse
- Use of NSAID, stereoids
- Subjects with wounds, ulcers in legs
- Subjects with hepatic, renal o neurologic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcutaneous Electrical Nerve Stimulation on Pain percepción and Serum Inflammatory Markers in Patients With Peripheral Diabetic Neuropathy
Double-blind, randomized, placebo-controlled, clinical trial. Patients with diabetic neuropathy will be randomly assigned to treatment with either TENS or TENS sham three times a week during 90 days. Clinical determinations are: pain, levesls of TNF-alpha, IL-6 and RPC-us
- Conditions
- Diabetic Neuropathy Peripheral
- Being tested
- Transcutaneous electrical neurostimulation
- Keywords
- Diabetic neuropathy peripheral, diabetic complications, TENS, Neuropathic treatments
- Medical subject headings
- Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical neurostimulationDevice
Sessions of 30 minutes of TENS will be applied three times a week during 90 days
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | Transcutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days Receives: Device: Transcutaneous electrical neurostimulation |
| Sham | Sham comparator | A sham comparator will be applied for 30 minutes three times a week during 90 days. The device does not emit electrical impulses Receives: Device: Transcutaneous electrical neurostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
Evaluation of neuropathic pain evaluated with VAS
Measured: Change from Baseline Pain perception at 90 days
Secondary outcomes (3)
Tumoral Necrosis Factor Alpha
Serum levels of TNF-alpha
Measured: Change from Baseline serum levels of TNF-alpha at 90 days
Interleukin-6
Serum levels of IL-6
Measured: Change from Baseline serum levels of IL-6 at 90 days
C Reactive Protein ultra-sensible
Serum levels of CRP-us
Measured: Change from Baseline serum levels of CRP-us at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Feb 2019
- Primary completion1 Sep 2020
- Study completion30 Jul 2021
Why it stopped: Due to pandemic od COVID-19, was difficult recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy PeripheralStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Tonalá
- Sponsor type
- University, hospital or other
- Collaborators
- University of Guadalajara, Diabetes sin Complicaciones S.A de C.V, Mexico
- Responsible party
- Principal investigator, Arieh Roldán Mercado Sesma, Centro Universitario de Tonalá
- Investigators
- Arieh R Mercado Sesma, PhD, Principal investigator, Salud Enfermedad como proceso individual, CUTonalá, Universidad de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253860
- Sponsor's protocol ID
- TENS-ND-2018
- Status last verified
- Jul 2021
- First submitted
- 30 Jan 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Nerve Stimulation on Pain percepción and Serum Inflammatory Markers in Patients With Peripheral Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT04253860
- Acronym / sponsor ID
- TENS-ND-2018
- Conditions
- Diabetic Neuropathy Peripheral
- Keywords
- Diabetic neuropathy peripheral, diabetic complications, TENS, Neuropathic treatments
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to pandemic od COVID-19, was difficult recruit patients
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centro Universitario de TonaláUniversity, hospital or other
- Collaborators
- University of Guadalajara, Diabetes sin Complicaciones S.A de C.V, Mexico
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 5 Feb 2020 (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.
Double-blind, randomized, placebo-controlled, clinical trial. Patients with diabetic neuropathy will be randomly assigned to treatment with either TENS or TENS sham three times a week during 90 days. Clinical determinations are: pain, levesls of TNF-alpha, IL-6 and RPC-us
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized, double-blind, clinical trial
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: Transcutaneous electrical neurostimulationTranscutaneous electrical neurostimulation will be applied for 30 minutes three times a week during 90 days |
| Sham | Sham comparator | Device: Transcutaneous electrical neurostimulationA sham comparator will be applied for 30 minutes three times a week during 90 days. The device does not emit electrical impulses |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnostic of type 2 diabetes > 10 years
- Diagnostic of peripheral diabetic neuropathy less than 5 years
- HbA1C > 6.5 and < 9%
- Plasmatic glucose >140 mg/dL and lees than 350 mg/dL
- Informed consent signed
Key exclusion criteria (6 listed)
- Use of implanted pacemaker or heart defibrillator
- Implanted brain stimulator
- History of alcohol abuse
- Use of NSAID, stereoids
- Subjects with wounds, ulcers in legs
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 |
|---|---|---|
| Transcutaneous electrical neurostimulationSessions of 30 minutes of TENS will be applied three times a week during 90 days | Device | Sham, TENS |
Primary outcome
Pain perception
Time frame: Change from Baseline Pain perception at 90 days
Evaluation of neuropathic pain evaluated with VAS
3 secondary outcomes
Tumoral Necrosis Factor Alpha
Time frame: Change from Baseline serum levels of TNF-alpha at 90 days
Interleukin-6
Time frame: Change from Baseline serum levels of IL-6 at 90 days
C Reactive Protein ultra-sensible
Time frame: Change from Baseline serum levels of CRP-us at 90 days
Results and safety
The study was stopped early (reason given: Due to pandemic od COVID-19, was difficult recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
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Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
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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.
Arieh R Mercado Sesma, PhD principal investigator
Salud Enfermedad como proceso individual, CUTonalá, Universidad de Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transcutaneous electrical neurostimulation in people with Diabetic Neuropathy Peripheral, run by Centro Universitario de Tonalá at 1 site in Mexico.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 4 Aug 2021. 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 Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to pandemic od COVID-19, was difficult recruit patients). Results are not available in the source record.
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?
Pain perception (time frame: Change from Baseline Pain perception at 90 days). 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 4 Aug 2021.