Effects of Terminalia fagifolia mart. extract combined with photobiomodulation on diabetic foot ulcers: protocol for a randomized single-blind clinical trial

Diabetic wounds are characterized by persistent inflammation, prolonged healing time, and an increased risk of amputation. The use of natural compounds combined with established therapies can increase the effectiveness of treatments for these lesions. In this context, natural products have stood out as therapeutic adjuvants due to their anti-inflammatory, antioxidant, antimicrobial, and regenerative properties. Terminalia fagifolia Mart., a medicinal species native to the Brazilian Cerrado, has a rich phytochemical composition; however, its clinical potential in wound healing has not yet been investigated. This is the first clinical trial to investigate the potential synergistic effects of Terminalia fagifolia Mart. extract, alone or in combination with photobiomodulation, on the healing of non-infected diabetic foot ulcers. A total of 102 participants with type 2 diabetes and lower limb ulcers will be randomly allocated into three groups: G1 (Terminalia fagifolia Mart. + wound occlusion), G2 (GaAs 904, 10 J/cm² + Terminalia fagifolia Mart. + wound occlusion), and a control group using Endophoton KLD (GaAs 904) at a dose of 10 J/cm² + conventional dressing. One hundred and two volunteers will be recruited and treated on two non-consecutive days per week for 10 weeks, totaling 20 sessions. The primary outcome variable will be the rate of ulcer size reduction over the 10-week period. This study is expected to provide preliminary evidence regarding the safety, feasibility, and potential efficacy of the synergistic use of T. fagifolia Mart. extract combined with photobiomodulation in the treatment of diabetic foot ulcers.Clinical trial registration This study was registered at Brazilian Clinical Trials Registry (ReBEC) on December 27, 2023 (RBR-25ng5pt || https://ensaiosclinicos.gov.br/rg/RBR-25ng5pt ).