Evaluation and Treatment for Diabetic Peripheral Neuropathy

January 10, 2026 updated by: Juliana da Silva Amaral Bruno, University of Sao Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Carlos, São Paulo, Brazil, 13569350
        • Research, Innovation and Development Support Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type II diabetes diagnosed between 7 and 15 years old;
  • Age between 45 and 70 years;
  • Sex female and male.

Exclusion Criteria:

  • 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;
  • Hemodialysis treatment;
  • Drug use;
  • Physiotherapy treatment for less than six months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diabetic Peripheral Neuropathy in Early Stages: Photobiomodulation and Therapeutic Ultrasound Treatm

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).
Device: Active Comparator

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 Comparator: Early diabetic peripheral neuropathy: Sham Group

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.
Device: Sham Group Arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 12 weeks of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Universidade Federal de Sao Carlos

Investigators

  • Study Director: Vanderlei Bagnato, Phd, University São Paulo
  • Study Chair: Cleber Ferraresi, Phd, University Federal of São Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2024

Primary Completion (Actual)

April 7, 2025

Study Completion (Actual)

May 20, 2025

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 10, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSAmaralBruno

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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