Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers.

NCT07798960 | Recruiting Phase 2

• 1 other identifier: DMPBMThermo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Foot ulcers in people with diabetes mellitus represent one of the most serious chronic complications of the disease, being associated with persistent inflammation, high oxidative stress, microvascular dysfunction and systemic hemorheological changes that compromise the progression of the healing process. Given the pathophysiological complexity of these injuries, therapeutic strategies capable of acting simultaneously on the local wound microenvironment and the systemic biological environment become relevant for optimizing tissue repair. This study aims to evaluate the effects of the association between transcutaneous vascular photobiomodulation (FBMVT) and topical photobiomodulation (FBMT) in people with diabetes and foot ulcers. This is a randomized, controlled and prospective phase II clinical trial, with a sample of 20 participants allocated to experimental groups that will receive a standard dressing with neutral healing matrix (TLC) or a protocol combining FBMVT and FBMT. FBMVT will be performed with a 660 nm laser, 100 mW power, continuous mode and 180 J per application, monthly for 12 weeks, totaling four sessions. FBMT will be performed with a 660 nm laser, 100 mW power, 2 J energy per point, twice a week during dressing changes, totaling approximately 24 sessions throughout follow-up. The primary outcome will be the reduction in the area of the lesion (cm²), measured using a standardized planimetric method. As secondary outcomes, the Pressure Ulcer Scale for Healing (PUSH) score will be evaluated, the standardized infrared thermographic assessment of the monthly perilesional region of all participants and the qualitative analysis of peripheral blood by dark field microscopy (MCE) pre and post FBMVT of the intervention group. The data will be analyzed using repeated measures ANOVA, after evaluating the normality of the data, adopting a significance level of 5%. It is expected to observe a reduction in the lesion area, improvement in clinical healing scores, favorable changes in the hemocirculatory dynamics observed in ECM and modulation of thermal patterns related to tissue perfusion, indicating that systemic and local biophotonic modulation can contribute to the optimization of the healing process in foot ulcers in people with diabetes.

Conditions

Diabetes Mellitus; Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Size of wound area

  Wound area (cm²). To obtain the wound area, a standardized two-dimensional measurement technique will be used, considering the greatest length (longitudinal axis) and the greatest width perpendicular to the length (transverse axis), with area estimated using the formula: Area (cm²) = length × width This method is widely accepted in clinical practice and clinical studies, especially when combined with evaluator standardization and systematic photographic documentation, and is recommended by international guidelines for longitudinal wound monitoring (IWGDF, 2023; EWMA, 2022).

  At the basal assessment (baseline), immediately before the PBM therapy, and 12 weeks of treatment

Secondary Outcomes (5)

• Rate of area reduction over time

  At the basal assessment (baseline), immediately before the weekly PBM therapy. and 12 weeks of treatment

• Healing Wound Progression

  At the basal assessment (baseline), and 12 weeks of treatment

• Pain Intensity

  At the basal assessment (baseline), immediately before the weekly PBM therapy, and 12 weeks of treatment

• Thermographic wound temperature

  At the basal assessment (baseline), and 12 weeks of treatment

• Blood cell morphology

  At the basal assessment (baseline), and 12 weeks of treatment

Study Arms (2)

PBM Treatment Group

ACTIVE COMPARATOR

PBM group

Radiation: PBM - Photobiomodulation; Other: Standard Treatment

PBM Placebo Group

PLACEBO COMPARATOR

PBM placebo group

Radiation: Placebo PBM; Other: Standard Treatment

Interventions

PBM - Photobiomodulation RADIATION

Application of transcutaneous PBM therapy to the foot ulcer Photobiomodulation (PBM)-formerly referred to as low-level laser therapy (LLLT) or cold laser therapy-is a non-invasive, non-thermal therapeutic modality that employs light in the red to near-infrared spectrum (typically spanning wavelengths from approximately 600 nm to 1,100 nm) to elicit beneficial biological responses in target tissues.

Also known as: Low Level Laser Therapy

PBM Treatment Group

Placebo PBM RADIATION

Application of transcutaneous PBM therapy - device switched off-

PBM Placebo Group

Standard Treatment OTHER

cutaneous standard dressing with neutral healing matrix (TLC)

Also known as: Standard dressing with neutral healing matrix (TLC)

PBM Placebo Group; PBM Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Adults,
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical diagnosis of Diabetes Mellitus type 1 or 2;
• Presence of a foot ulcer with duration ≥ 4 weeks, characterizing a chronic ulcer;
• Age ≥ 18 years;
• Ankle-brachial index compatible with adequate perfusion, allowing for the safe conduct of treatment;
• Wagner Grade I or Wagner Grade II classification of DM ulcer
• Ability to understand the objectives of the study and signature of the ICF (Informed Consent Form). -

You may not qualify if:

• Having more than one ulcer to be treated, regardless of etiology;
• Presence of hematological diseases that may interfere with peripheral blood analysis, such as: hemolytic anemias, hemoglobinopathies (sickle cell anemia), leukemias, lymphomas, multiple myeloma, or other blood dyscrasias that may significantly interfere with cell morphology or peripheral blood analysis;
• Active systemic infection at the time of enrollment;
• Active neoplasia undergoing treatment or under investigation;
• Use of immunosuppressants or corticosteroids;
• Pregnant or breastfeeding women;
• Use of photosensitizing medications;
• Allergy or sensitivity to any of the study interventions;
• Clinical signs of infection, necrosis, devitalized tissue, or wound colonization.
• Acute clinical conditions that contraindicate participation, whether related or unrelated to DM.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Estadual do Piaui

Teresina, Piauí, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Foot Ulcer

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Rebeca B Cecatto, Ph.D.

CONTACT

11970842496; rebeca.boltes@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor M.D. Ph.D.

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: May 12, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Locations

BR (1)