The effect of platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C for treatment of non-healing diabetic foot ulcers: A randomized, double-blind, parallel-group, clinical trial.

OBJECTIVE The current study assesses the effects of platelet-rich plasma-fibrin glue (PRP-FG) dressing along with oral vitamin E and C on wound healing and biochemical markers in patients with non-healing diabetic foot ulcers (non-healing DFU). METHODS This randomized, double-blind, placebo-controlled trial was performed on twenty-five patients with non-healing DFU. Patients were treated with PRP-FG dressing plus oral vitamin E and C (intervention group) or PRP-FG dressing plus placebo (control group) for eight weeks. RESULTS Eight weeks after treatment, six wounds in the intervention group and two wounds in the control group were completely closed, and also wound size significantly reduced in both intervention (-9.7 ± 6.9 cm2, p = 0.002), and control (-5.6 ± 5.4 cm2, p = 0.003) groups. This reduction in wound size was significantly greater in the intervention group compared to the control group (p = 0.019). Also, a significant decrease in prooxidant-antioxidant balance (PAB) index, ESR, and hs-CRP were observed in the intervention group compared to the control group (p < 0.05). CONCLUSION Results of this trial showed that PRP-FG dressing along with oral vitamin E and C could be used to increase wound healing in patients with non-healing DFU by enhancing the wound healing process and reducing oxidative stress. TRIAL REGISTRATION This trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04315909).