Effects and Feasibility of Photobiomodulation at 830nm Nanometers in the Treatment of Diabetic Ulcers

NCT07043868 | Not Yet Recruiting DMC

• 1 other identifier: 7.488.044
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

Brief Summary

Diabetic foot ulcers (DFU) are among the late complications of DFU, defined as skin lesions that involve the dermis to deeper structures, such as muscles and bones. Although preclinical studies have demonstrated the effects of GaAs 830 nm in diabetic wounds, no clinical studies have been performed, revealing the need for more in-depth analyses to identify the effects and ideal parameterization of PBM with GaAs 830 nm wavelength in the treatment of diabetic ulcers, improving quality of life, as well as to understand the therapeutic feasibility, time required for healing and recurrence rates of these lesions. Experimental, randomized, controlled, double-blind study, with blinding applied to the evaluator and participants. A total of 136 volunteers will be recruited for the research, carried out at the Integrated Center of Medical Specialties (CIEM) - Polyclinic. LLLT GaAs 830nm will be used with three dosages of low, medium and high intensity (4 J/cm², 8 J/cm², 12 J/cm²). The study will have three intervention groups using LLLT with GaAs 830nm and a control group, in which LLLLT will be performed with a GaAs 904nm wavelength and a dose of 10 J/cm², according to Saura et al (2024). This study was approved by the local Research Ethics Committee (Opinion 7,488,044), conducted in accordance with the Declaration of Helsinki and in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines.

Conditions

Diabete Type 2; Diabetic Foot Ulcer; Photobiomodulation; Low Level Laser Therapy

Keywords

diabetic foot ulcer; photobiomodulation; low level laser therapy

Outcome Measures

Primary Outcomes (1)

• Ulcer area reduction rate

  The ulcers will be measured with a paper ruler and photographed for later analysis of the images using the ImageJ program. The paper ruler will be positioned to measure the length and width of the ulcers.

  Pre-intervention, five weeks and ten weeks of treatment

Secondary Outcomes (4)

• University of Texas Rankings

  Pre-intervention, five weeks and ten weeks of treatment

• Quality of life assessment

  Pre-intervention, five weeks and ten weeks of treatment

• Glycemic level assessment

  Once a week for ten weeks (20 sessions)

• Analysis of healing time and recurrence rate

  Quarterly follow-up (3 months) after initial healing

Study Arms (4)

CG + conventional dressing

ACTIVE COMPARATOR

The group will receive application of Gallium Arsenide LASER (GasAs) 904nm 10J/cm2 associated with Helianthus annuus oil dressing.

Device: Low Level Laser Therapy

GL1 4J/cm2 +conventional dressing

EXPERIMENTAL

The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 4 J/cm² associated with Helianthus annuus oil dressing.

Device: Low Level Laser Therapy

GL2 8J/cm2 +conventional dressing

EXPERIMENTAL

The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 8J/cm² associated with Helianthus annuus oil dressing.

Device: Low Level Laser Therapy

GL1 12J/cm2 +conventional dressing

EXPERIMENTAL

The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 12J/cm² associated with Helianthus annuus oil dressing.

Device: Low Level Laser Therapy

Interventions

Low Level Laser Therapy DEVICE

Painless, non-invasive treatment

Also known as: Photobiomodulation

CG + conventional dressing; GL1 12J/cm2 +conventional dressing; GL1 4J/cm2 +conventional dressing; GL2 8J/cm2 +conventional dressing

Eligibility Criteria

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

You may qualify if:

• Volunteers of both sexes
• Age over 18 years
• Medical diagnosis of diabetes mellitus (DM)
• Presence of diabetic ulcer

You may not qualify if:

• Autoimmune diseases
• Infected diabetic ulcers
• Osteomyelitis
• Ischemia
• Concomitant psychiatric disorders
• Contraindications to treatment methods

Sponsors & Collaborators

• Federal University of Piaui: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Foot

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Vinicius Saura Vinicius Saura Cardoso

CONTACT

55 86 99984-2919; vscfisio@ufdpar.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: June 29, 2025
• Study Start: January 10, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): January 10, 2028
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share