Randomised controlled clinical trial for autologous fibroblast-hyaluronic acid complex in treating diabetic foot ulcers

Objective: Diabetic foot ulcers (DFUs) often pose a treatment problem. Bioengineered skin substitutes have been reported to result in accelerated diabetic wound healing. The purpose of this clinical trial was to evaluate the efficacy and safety of the autologous fibroblast-hyaluronic acid complex for treating DFUs. Method: A stratified, randomised, controlled, multicentre study was carried out. Patients with DFUs were allocated to either a treatment group with grafting of an autologous fibroblast-hyaluronic acid complex or a control group with non-adherent foam dressing. Except for application of the fibroblast complex, treatment of the study ulcers was identical for patients in both groups. The maximum follow-up period for each patient was 12 weeks. Results: Complete ulcer healing was achieved in 84% (26/31 patients) of the treatment group and 34% (11/32 patients) of the control group (p<0.05). The times required for complete healing were 36.4±17.6 and 48.4±13.1 days in the treatment and control groups, respectively (p<0.05). No adverse events related to treatment occurred. Conclusion: These results indicate that autologous fibroblast-hyaluronic acid complex may offer a safe and effective treatment for DFUs. Declaration of interest: This study was supported by grants from ChaBio & Diostech (Seoul, Korea). This clinical trial was approved by the FDA of Korea. None of the authors have any conflicts of interest.