A prospective randomized controlled study on topical autologous platelet-rich plasma gel for the treatment of diabetic non-healing dermal ulcers / 中国糖尿病杂志

ABSTRACT

Objective To compare the safety and effectiveness between treatments with autologous platelet gel (APG) versus standard care for treating refractory diabetic dermal ulcers.Methods The 46 patients with proved nonhealing diabetic dermal ulcers were enrolled. Eligible for the study were patients with grade II/III ulcers according to Wagner, lasting for at least 2 weeks and with no signs of infection at recruitment.Patients were given their informed consent document and randomly assigned to two groups standard care (ST, n=23) or standard care plus topic application of APG (APG, n=23) for twelve weeks.The treatment of blood glucose, blood pressure and lipids was optimized and the empiric antibiotic treatment was further adjusted according to the results of culture and sensitivity testing in all patients. APG treatment consisted of wound dressing with APG, followed by topical washing and cleaning. The APG was then covered with vaseline gauze for 72 hours, after which the ulcers were treated by standard care. Participants were seen thrice a week, twice a week, or at weekly intervals. Twelve weeks observation was set as the end point.Results The would of APG group were improved in 22 patients with ulcers healed completely and 1 case with would area reduced. In the ST group, 13 ulcers were healed, 6 worsened and 4 with would area reduced. The cumulative rate of ulcer healing was 95.7% in the APG group versus 56.5% in the ST group (P=0.002). The total effective rate in APG vs ST group was 100.0% vs 73.9% (P=0.009). By Kaplan-Meier analysis,the time-to-healing of ulcer and time-to-lutation of sinus were significantly different between two groups (log-rank, P=0.006, 0.000, respectively). No treatment-related adverse events were observed. Conclusions Treatment with APG in addition to standard care results in a significantly faster and better healing for a refractory diabetic dermal ulcer and does not raise any safety concerns. So APG treatment can be a valuable and effective aid in the management of diabetic foot ulcers.