Antimicrobial photodynamic therapy improves wound quality and tissue repair in diabetic foot ulcers: A randomized double blind controlled clinical trial.

Diabetic foot ulcers have a substantial negative impact on patients' quality of life. This double blind, randomized clinical trial evaluated the association of antimicrobial photodynamic therapy (aPDT) used as an adjunct to standard wound care with wound quality and tissue repair using the Bates-Jensen Wound Assessment Tool (BWAT). Patients were randomly allocated into an aPDT group or a control group, both receiving standard wound care. The intervention consisted of treatment with a cluster of red lasers (660 nm) combined with a 1% methylene blue photosensitizer. Clinical evaluations were performed over ten treatment sessions, with an additional follow-up conducted 30 days after the final application. The aPDT group demonstrated a significant reduction in BWAT clinical scores from the third treatment session onward, with improvements maintained at the 30-day follow-up, indicating significant short-term improvement in tissue repair. Additional clinical assessment scales also showed significant improvements exclusively in the aPDT group, particularly regarding ischemic condition, epithelialization, and overall skin integrity. No worsening of clinical outcomes was observed, and no treatment-related adverse events were reported during the study period. In conclusion, adjunctive antimicrobial photodynamic therapy was associated with significant short-term improvements in wound quality and tissue repair when combined with standard wound care, and was well tolerated during the study period.