Evaluation of the Effectiveness of Hyodine on Healing of Diabetic Foot Ulcer: A Randomized Single-Blind Controlled Trial

Introduction: Diabetic foot ulcers (DFUs) pose a significant global health threat. It is estimated that individuals with diabetes have a 15–34% lifetime risk of developing a foot ulcer. This clinical study evaluates the comparative effectiveness of Hyodine solution versus standard treatment protocols in promoting the healing of DFUs. Methods: This prospective, multicenter, single-blind randomized clinical trial enrolled 98 patients with type 1 and 2 diabetes who presented with grade 1-2 infected diabetic foot ulcers from participating diabetes clinics between June 2023 and January 2025. Patients were randomly divided into two groups by block randomization in a 4:1 ratio: a control group that received standard treatment and an intervention group (Hyodine) that received standard treatment plus an iodine solution. Wound cultures were obtained three times during the study: at baseline (before treatment initiation), week 2, and week 4. The collected data were analyzed using SPSS 20 software. Result: In our study, 98 patients with diabetic foot ulcers participated. Intervention group (n = 49): received Hyodine treatment, and the control group (n = 49) received standard wound care, for four weeks. The average age of the participants was 60 ± 11.46 years. Among the participants, 30 patients (30.6%) were females, and 63.3% of the individuals had a history of diabetic foot ulcer. The colony counts significantly decreased by the end of the study compared to the beginning of the study (p<0.001) in the intervention group. The difference in wound area in the Hyodine group between the first and last visits was statistically significant (P < 0.05). Discussion: These results align with growing evidence that hyaluronic acid-based treatments, such as Hyodine, enhance antimicrobial activity and accelerate wound healing in chronic diabetic foot ulcers. Conclusion: To reduce complications from diabetic foot ulcers, the implementation of advanced therapeutic interventions is critical for alleviating the burden on both patients and healthcare systems.