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Evaluation and Treatment for Diabetic Peripheral Neuropathy

NCT07317284 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-13

No results posted yet for this study

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

Interventions

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).

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.

Sponsors & Collaborators

  • Universidade Federal de Sao Carlos

    collaborator OTHER

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Vanderlei Bagnato, Phd · University São Paulo

  • Cleber Ferraresi, Phd · University Federal of São Carlos

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-04-07
Completion
2025-05-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07317284 on ClinicalTrials.gov