NCT07317284

Evaluation and Treatment for Diabetic Peripheral Neuropathy

Evaluation of Peripheral Neurological Integrity and Synergistic Treatment of Photobiomodulation and Therapy Ultrasound in Patirnts With Diabetes Mellitus (Type II): Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-10
• Primary completion: 2025-04-07
• Completion: 2025-05-20
• First posted: 2026-01-05
• Last updated: 2026-01-13

Locations

1 site across 1 country: Brazil