Evaluation and Treatment for Diabetic Peripheral Neuropathy

NCT07317284 | Completed

• 1 other identifier: JSAmaralBruno
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Diabetic Neuropathy Peripheral

Keywords

Diabetes Mellitus 2 Type; Diabetic Neuropathy; Photobiomodulation Therapy; Ultrasound Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and after 12 weeks of intervention.

Study Arms (2)

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).

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.

Device: Sham Group Arm

Interventions

Active Comparator DEVICE

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).

Diabetic Peripheral Neuropathy in Early Stages: Photobiomodulation and Therapeutic Ultrasound Treatm

Sham Group Arm DEVICE

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.

Early diabetic peripheral neuropathy: Sham Group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Universidade Federal de Sao Carlos: collaborator

Study Sites (1)

Research, Innovation and Development Support Center

São Carlos, São Paulo, 13569350, Brazil

Location

Related Publications (3)

• 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

  RESULT

• 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.

  PMID: 29480363 RESULT

• Cheng 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.

  PMID: 33636371 RESULT

Related Links

• Description Optics and Photonics Research Center

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Study Officials

• Vanderlei Bagnato, Phd

  University São Paulo

  STUDY DIRECTOR

• Cleber Ferraresi, Phd

  University Federal of São Carlos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study's methodological design was double-blind: the evaluators responsible for measuring the outcomes had no prior knowledge of the type of intervention the participants underwent; and the participants themselves were also unaware of which treatment (active or sham) they were receiving. It is worth noting that the researchers responsible for administering the intervention were unaware of the results of the participants' initial assessments and did not participate in the final analyses. This methodological structure directly contributed to reducing observational and analytical biases, promoting greater reliability of the findings.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 5, 2026
• Study Start: July 10, 2024
• Primary Completion: April 7, 2025
• Study Completion: May 20, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)