Antimicrobial Photodynamic Therapy in the Treatment of Diabetic Foot Ulcers: A Pilot Randomized Clinical Trial
Abstract
This pilot randomized clinical trial evaluated photodynamic therapy (PDT) in diabetic foot ulcers (DFUs), comparing an intervention group (IG, n = 5) with a control group (CG, n = 4). Participants were followed for 7 weeks. The IG received PDT, while the CG underwent conventional care. The microbiological profile was assessed by biopsy before and after treatment, and wound progression was evaluated using the Bates-Jensen Wound Assessment Tool. In the IG, only one participant showed an increase in the number of bacterial species, while the others maintained the count with changes in species composition. In the CG, two participants presented an increase in bacterial species. All participants in the IG showed a reduction in ulcer size, with an average decrease of more than 63%, whereas two participants in the CG exhibited an increase in lesion area. These results suggest clinically relevant differences, supporting PDT as a promising adjuvant strategy for antimicrobial stewardship in DFUs.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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