Diabetic Neuropathy PeripheralNCT07317284
Evaluation and Treatment for Diabetic Peripheral Neuropathy
A study testing Active Comparator in people with Diabetic Neuropathy Peripheral, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims: To compare conventional diabetic neuropathy screening techniques with user-friendly technological equipment; To evaluate the effects of the combined application of laser and therapeutic ultrasound in the treatment of Diabetic Peripheral Neuropathy (DPN) in its early stages, aiming to prevent severe… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Diabetic Neuropathy Peripheral
- What is being tested?
- Active Comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jul 2024to 20 May 2025
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type II diabetes diagnosed between 7 and 15 years old;
- Age between 45 and 70 years;
- Sex female and male.
Who cannot join
- Diabetic foot;
- Lower limb involvement with metal implants, ankle and foot fractures;
- Serious illnesses such as malignant or benign tumors;
- Serious psychological problems;
- Hormonal disorders;
- Pacemaker users;
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- Hemodialysis treatment;
- Drug use;
- Physiotherapy treatment for less than six months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Research, Innovation and Development Support Center
São Carlos, São Paulo, 13569350
About this study
Official title: Evaluation of Peripheral Neurological Integrity and Synergistic Treatment of Photobiomodulation and Therapy Ultrasound in Patirnts With Diabetes Mellitus (Type II): Clinical Study
This study aims:
- To compare conventional diabetic neuropathy screening techniques with user-friendly technological equipment;
- To evaluate the effects of the combined application of laser and therapeutic ultrasound in the treatment of Diabetic Peripheral Neuropathy (DPN) in its early stages, aiming to prevent severe complications, such as the development of diabetic foot.
Two groups were formed: Treatment group and placebo group. 24 sessions were performed (twice a week, on alternate days). It is concluded that the combined treatment with laser and therapeutic ultrasound for diabetic peripheral neuropathy promotes a significant reduction in symptoms and improvement in sensitivity in patients with diabetic peripheral neuropathy.
Read the detailed description
Diabetes Mellitus (DM) is a chronic disease that currently affects approximately 589 million adults, aged between 20 and 79 years, worldwide. Alarming projections indicate that, by 2050, this number could exceed 853 million individuals in the same age group. The DPN is one of the most common complications of DM, characterized by a set of syndromes with diverse clinical and subclinical manifestations. The neurological damage tends to be extensive, largely compromising the peripheral nervous system in its sensorimotor and autonomic components. The pain has variable intensity, being a constant complaint, commonly described as tingling, burning or a sensation of pins and needles in the extremities, often accompanied by abnormal sensory changes, such as allodynia and hyperalgesia. Early diagnosis of DPN and ongoing monitoring are essential, as they promote education and awareness among diabetic patients, in addition to contributing to delaying or minimizing more serious complications as the disease progresses. This study aims to compare conventional diabetic neuropathy screening techniques with technological and easy-to-use equipment and, from there, evaluate the effects of the combined application of photobiomodulation and therapeutic ultrasound in the treatment of DPN in its early stages, aiming to prevent severe complications, such as the development of diabetic foot (sensory nerve).
Sixty participants were recruited and evaluated with various DPN screening instruments. They were then randomly assigned to two groups: a treatment group and a control group.
The treatment group received combined stimulation with photobiomodulation and therapeutic ultrasound in the sural nerve region, with the following parameters: continuous laser, wavelength of 808 nm, and therapeutic ultrasound with a frequency of 1 MHz, pulsed mode, for 6 minutes on each sural nerve, with rotational movement of the transducer.
The results of objective assessments performed with the DPN Check® showed that, in the treatment group, there was an increase in the "normal" rating, while the "moderate" rating, which was predominant at baseline, increased. In subjective assessments, considering a broad analysis of nerve fiber types, the "normal" rating increased while the "moderate" rating decreased. In the control group, the "normal" rating remained low, and the "moderate" rating remained at 70% in objective assessments. In the subjective evaluations, there was no change in the "normal" classification (remaining at 0% from start to finish), and the "moderate" classification varied little.
- Conditions
- Diabetic Neuropathy Peripheral
- Being tested
- Active Comparator, Sham Group Arm
- Keywords
- Diabetes Mellitus 2 Type, Diabetic Neuropathy, Photobiomodulation Therapy, Ultrasound Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ComparatorDevice
Participants allocated to the experimental arm will receive a combined photobiomodulation (PBM) and therapeutic ultrasound (TUS) protocol applied bilaterally over the anatomical pathway of the sural nerve, using the Recupero device (MMOptics, São Carlos, São Paulo, Brazil), which integrates both PBM and TUS modalities for research and clinical applications.
Therapeutic ultrasound parameters: 1 MHz frequency, pulsed mode (50% duty cycle), secondary frequency of 100 Hz, intensity of 0.8 W/cm² , energy density of 144 J/cm².
Photobiomodulation parameters: 808-nm infrared wavelength, continuous mode, 100 mW power, irradiation area of 0.125 cm², resulting in 36 J total energy per session (286 J/cm²).
Sham Group ArmDevice
Participants allocated to the control arm will undergo a sham procedure designed to mimic the experimental intervention without delivering therapeutic energy. The same device will be used (RECUPERO, MMOptics, São Carlos, São Paulo, Brazil) with minimal ultrasound therapy settings: 1 MHz frequency, 50% duty cycle, secondary frequency of 16 Hz, intensity of 0.1 W/cm², energy density of 18 J/cm². The photobiomodulation emitter will remain off to ensure no light emission.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Peripheral Neuropathy in Early Stages: Photobiomodulation and Therapeutic Ultrasound Treatm | Active comparator | Arm experimental:
Participants allocated to the experimental arm will receive a combined photobiomodulation (PBM) and therapeutic ultrasound (TUS) protocol applied bilaterally over the anatomical pathway of the sural nerve. TUS parameters: 1 MHz frequency, pulsed mode (50% duty cycle), secondary frequency of 100 Hz, intensity of 0.8 W/cm², energy density of 144 J/cm². PBM parameters: 808-nm infrared wavelength, continuous mode, 100 mW power, irradiation area of 0.125 cm², resulting in 36 J total energy per session (286 J/cm²). Receives: Device: Active Comparator |
| Early diabetic peripheral neuropathy: Sham Group | Sham comparator | Arm Control (Sham):
Participants allocated to the control arm will undergo a sham procedure designed to mimic the experimental intervention without delivering therapeutic energy. The same device will be used with minimal TUS settings: 1 MHz frequency, 50% duty cycle, secondary frequency of 16 Hz, intensity of 0.1 W/cm², energy density of 18 J/cm². The PBM emitter will remain off to ensure no light emission. Receives: Device: Sham Group Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuropathic pain intensity
Changes in the severity of neuropathic symptoms (pain, burning, tingling, and numbness) in patients with diabetic peripheral neuropathy were evaluated using the following instruments: (1) Neuropathy Disability Score (NDS), a clinical scale that quantifies neuropathic severity through neurological examination. Scores range from 0 to 10 points, with higher values indicating greater neurological impairment and worse clinical outcomes, and lower values reflecting better neurological function. (2) DPN-Check, a validated point-of-care diagnostic device used to assess diabetic peripheral neuropathy by measuring sural nerve conduction velocity (NCV, m/s) and sensory nerve action potential (SNAP) amplitude (µV) through a standardized, noninvasive electrophysiological assessment. The device reports NCV values from 20 to 70 m/s and SNAP amplitude values from 0 to 32 µV. Values ≥ 4 µV and ≥ 40 m/s are considered normal, whereas lower values indicate peripheral nerve dysfunction.
Measured: Baseline and after 12 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start10 Jul 2024
- Primary completion7 Apr 2025
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathy PeripheralStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The clinical trial was randomized, with 60 volunteers (men and women) with diabetes mellitus (type II) following the inclusion and exclusion criteria. To form the experimental groups, three pots (1, 2, 3) were prepared, and the distribution of participants into the groups respected the degree of neuropathic impairment, classified as mild (pot 1), moderate (pot 2), or severe (pot 3) based on the results obtained by assessing nerve conduction velocity measured by the DPN Check® equipment, then used to assess sural nerve function. Sixty envelopes, numbered sequentially from 1 to 60, were also prepared and placed in the jars, using simple randomization. Even numbers were assigned to Group 1, which received synergistic treatment with photobiomodulation and therapeutic ultrasound; and odd numbers were assigned to Group 2, which received sham treatment (control group). Thus, each participant was instructed to choose an envelope from the jar corresponding to their level of impairment, in order
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Sao Carlos
- Responsible party
- Principal investigator, Juliana da Silva Amaral Bruno, Universidade Federal de Sao Carlos
- Investigators
- Vanderlei Bagnato, Phd, Study director, University São PauloCleber Ferraresi, Phd, Study chair, University Federal of São Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317284
- Sponsor's protocol ID
- JSAmaralBruno
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang J, Wu Y, Li J, et al. Synergistic effects of photobiomodulation and mechanical stimulation on nerve regeneration. Lasers in Medical Science. 2022;37(4):1931-1942. PMID: 35184274
Paolillo FR, Paolillo AR, Joao JP, Frasca D, Duchene M, Joao HA, Bagnato VS. Ultrasound plus low-level laser therapy for knee osteoarthritis rehabilitation: a randomized, placebo-controlled trial. Rheumatol Int. 2018 May;38(5):785-793. doi: 10.1007/s00296-018-4000-x. Epub 2018 Feb 26.
PubMed 29480363Cheng K, Martin LF, Slepian MJ, Patwardhan AM, Ibrahim MM. Mechanisms and Pathways of Pain Photobiomodulation: A Narrative Review. J Pain. 2021 Jul;22(7):763-777. doi: 10.1016/j.jpain.2021.02.005. Epub 2021 Feb 23.
PubMed 33636371
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peripheral Neurological Integrity and Synergistic Treatment of Photobiomodulation and Therapy Ultrasound in Patirnts With Diabetes Mellitus (Type II): Clinical Study
- ClinicalTrials.gov ID
- NCT07317284
- Acronym / sponsor ID
- JSAmaralBruno
- Conditions
- Diabetic Neuropathy Peripheral
- Keywords
- Diabetes Mellitus 2 Type, Diabetic Neuropathy, Photobiomodulation Therapy, Ultrasound Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Universidade Federal de Sao Carlos
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 5 Jan 2026 (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 aims:
- To compare conventional diabetic neuropathy screening techniques with user-friendly technological equipment;
- To evaluate the effects of the combined application of laser and therapeutic ultrasound in the treatment of Diabetic Peripheral Neuropathy (DPN) in its early stages, aiming to prevent severe complications, such as the development of diabetic foot.
Two groups were formed: Treatment group and placebo group. 24 sessions were performed (twice a week, on alternate days). It is concluded that the combined treatment with laser and therapeutic ultrasound for diabetic peripheral neuropathy promotes a significant reduction in symptoms and improvement in sensitivity in patients with diabetic peripheral neuropathy.
Detailed description
Diabetes Mellitus (DM) is a chronic disease that currently affects approximately 589 million adults, aged between 20 and 79 years, worldwide. Alarming projections indicate that, by 2050, this number could exceed 853 million individuals in the same age group. The DPN is one of the most common complications of DM, characterized by a set of syndromes with diverse clinical and subclinical manifestations. The neurological damage tends to be extensive, largely compromising the peripheral nervous system in its sensorimotor and autonomic components. The pain has variable intensity, being a constant complaint, commonly described as tingling, burning or a sensation of pins and needles in the extremities, often accompanied by abnormal sensory changes, such as allodynia and hyperalgesia. Early diagnosis of DPN and ongoing monitoring are essential, as they promote education and awareness among diabetic patients, in addition to contributing to delaying or minimizing more serious complications as the disease progresses. This study aims to compare conventional diabetic neuropathy screening techniques with technological and easy-to-use equipment and, from there, evaluate the effects of the combined application of photobiomodulation and therapeutic ultrasound in the treatment of DPN in its early stages, aiming to prevent severe complications, such as the development of diabetic foot (sensory nerve).
Sixty participants were recruited and evaluated with various DPN screening instruments. They were then randomly assigned to two groups: a treatment group and a control group.
The treatment group received combined stimulation with photobiomodulation and therapeutic ultrasound in the sural nerve region, with the following parameters: continuous laser, wavelength of 808 nm, and therapeutic ultrasound with a frequency of 1 MHz, pulsed mode, for 6 minutes on each sural nerve, with rotational movement of the transducer.
The results of objective assessments performed with the DPN Check® showed that, in the treatment group, there was an increase in the "normal" rating, while the "moderate" rating, which was predominant at baseline, increased. In subjective assessments, considering a broad analysis of nerve fiber types, the "normal" rating increased while the "moderate" rating decreased. In the control group, the "normal" rating remained low, and the "moderate" rating remained at 70% in objective assessments. In the subjective evaluations, there was no change in the "normal" classification (remaining at 0% from start to finish), and the "moderate" classification varied little.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The clinical trial was randomized, with 60 volunteers (men and women) with diabetes mellitus (type II) following the inclusion and exclusion criteria. To form the experimental groups, three pots (1, 2, 3) were prepared, and the distribution of participants into the groups respected the degree of neuropathic impairment, classified as mild (pot 1), moderate (pot 2), or severe (pot 3) based on the results obtained by assessing nerve conduction velocity measured by the DPN Check® equipment, then used to assess sural nerve function. Sixty envelopes, numbered sequentially from 1 to 60, were also prepared and placed in the jars, using simple randomization. Even numbers were assigned to Group 1, which received synergistic treatment with photobiomodulation and therapeutic ultrasound; and odd numbers were assigned to Group 2, which received sham treatment (control group). Thus, each participant was instructed to choose an envelope from the jar corresponding to their level of impairment, in order
| Arm | Type | Receives |
|---|---|---|
| Diabetic Peripheral Neuropathy in Early Stages: Photobiomodulation and Therapeutic Ultrasound Treatm | Active comparator | Device: Active ComparatorArm experimental: Participants allocated to the experimental arm will receive a combined photobiomodulation (PBM) and therapeutic ultrasound (TUS) protocol applied bilaterally over the anatomical pathway of the sural nerve. TUS parameters: 1 MHz frequency, pulsed mode (50% duty cycle), secondary frequency of 100 Hz, intensity of 0.8 W/cm², energy density of 144 J/cm². PBM parameters: 808-nm infrared wavelength, continuous mode, 100 mW power, irradiation area of 0.125 cm², resulting in 36 J total energy per session (286 J/cm²). |
| Early diabetic peripheral neuropathy: Sham Group | Sham comparator | Device: Sham Group ArmArm Control (Sham): Participants allocated to the control arm will undergo a sham procedure designed to mimic the experimental intervention without delivering therapeutic energy. The same device will be used with minimal TUS settings: 1 MHz frequency, 50% duty cycle, secondary frequency of 16 Hz, intensity of 0.1 W/cm², energy density of 18 J/cm². The PBM emitter will remain off to ensure no light emission. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type II diabetes diagnosed between 7 and 15 years old;
- Age between 45 and 70 years;
- Sex female and male.
Key exclusion criteria (9 listed)
- Diabetic foot;
- Lower limb involvement with metal implants, ankle and foot fractures;
- Serious illnesses such as malignant or benign tumors;
- Serious psychological problems;
- Hormonal disorders;
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 |
|---|---|---|
| Active ComparatorParticipants allocated to the experimental arm will receive a combined photobiomodulation (PBM) and therapeutic ultrasound (TUS) protocol applied bilaterally over the anatomical pathway of the sural nerve, using the Recupero device (MMOptics, São Carlos, São Paulo, Brazil), which integrates both PBM and TUS modalities for research and clinical applications. Therapeutic ultrasound parameters: 1 MHz frequency, pulsed mode (50% duty cycle), secondary frequency of 100 Hz, intensity of 0.8 W/cm² , energy density of 144 J/cm². Photobiomodulation parameters: 808-nm infrared wavelength, continuous mode, 100 mW power, irradiation area of 0.125 cm², resulting in 36 J total energy per session (286 J/cm²). | Device | Diabetic Peripheral Neuropathy in Early Stages: Photobiomodulation and Therapeutic Ultrasound Treatm |
| Sham Group ArmParticipants allocated to the control arm will undergo a sham procedure designed to mimic the experimental intervention without delivering therapeutic energy. The same device will be used (RECUPERO, MMOptics, São Carlos, São Paulo, Brazil) with minimal ultrasound therapy settings: 1 MHz frequency, 50% duty cycle, secondary frequency of 16 Hz, intensity of 0.1 W/cm², energy density of 18 J/cm². The photobiomodulation emitter will remain off to ensure no light emission. | Device | Early diabetic peripheral neuropathy: Sham Group |
Primary outcome
Change in neuropathic pain intensity
Time frame: Baseline and after 12 weeks of intervention.
Changes in the severity of neuropathic symptoms (pain, burning, tingling, and numbness) in patients with diabetic peripheral neuropathy were evaluated using the following instruments: (1) Neuropathy Disability Score (NDS), a clinical scale that quantifies neuropathic severity through neurological examination. Scores range from 0 to 10 points, with higher values indicating greater neurological impairment and worse clinical outcomes, and lower values reflecting better neurological function. (2) DPN-Check, a validated point-of-care diagnostic device used to assess diabetic peripheral neuropathy by measuring sural nerve conduction velocity (NCV, m/s) and sensory nerve action potential (SNAP) amplitude (µV) through a standardized, noninvasive electrophysiological assessment. The device reports NCV values from 20 to 70 m/s and SNAP amplitude values from 0 to 32 µV. Values ≥ 4 µV and ≥ 40 m/s are considered normal, whereas lower values indicate peripheral nerve dysfunction.
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 13 Jan 2026.
- Results publicationWang J, Wu Y, Li J, et al. Synergistic effects of photobiomodulation and mechanical stimulation on nerve regeneration. Lasers in Medical Science. 2022;37(4):1931-1942. PMID: 35184274
- Results publication: PubMed 29480363Paolillo FR, Paolillo AR, Joao JP, Frasca D, Duchene M, Joao HA, Bagnato VS. Ultrasound plus low-level laser therapy for knee osteoarthritis rehabilitation: a randomized, placebo-controlled trial. Rheumatol Int. 2018 May;38(5):785-793. doi: 10.1007/s00296-018-4000-x. Epub 2018 Feb 26.
- Results publication: PubMed 33636371Cheng K, Martin LF, Slepian MJ, Patwardhan AM, Ibrahim MM. Mechanisms and Pathways of Pain Photobiomodulation: A Narrative Review. J Pain. 2021 Jul;22(7):763-777. doi: 10.1016/j.jpain.2021.02.005. Epub 2021 Feb 23.
- Description Optics and Photonics Research CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Vanderlei Bagnato, Phd study director
University São Paulo
Cleber Ferraresi, Phd study chair
University Federal of São Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator in people with Diabetic Neuropathy Peripheral, run by University of Sao Paulo at 1 site in Brazil.
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 9 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 13 Jan 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 Brazil. 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?
Change in neuropathic pain intensity (time frame: Baseline and after 12 weeks of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07317284, which also lists 3 linked publications.
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 13 Jan 2026.