A randomized controlled study of platelet-rich gel in treatment of refractory diabetic foot ulcer

Abstract

Objetive To evaluate the efficacy and safety of platelet–rich gel(PRG) in the treatment of the refractory diabetic foot ulcers. Methods A total of Sixty-two patients with refractory diabetic foot ulcer were recruited, from June 1, 2013 to September 1, 2014. All patients were randomly assigned into the conventional group(n=31) and PRG group(n=31) by the method of random number generator. Both groups were treated with general support and wound managed as usual. Wound treatments were same for two groups such as off–loading, debridement, dressing change, improvement of blood perfusion and anti–infection if necessary. The wounds of PRG group were treated with PRG according to wound volume to extract blood,and then covered with petrolatum gauze,after completely cleaning and regular treatment. Wounds were observed 3 days after enrollment, and every week until healed completely or in the end of 12 weeks observing period. The t,u and χ2 tests were used for comparing baseline data and healing efficacy. Kaplan–Meier survival analysis was used for comparing cumulative ulcer healing rate over time between two groups, Cox regression analysis was used for screening the factors influencing healing. Results The healing efficacy (including poor, better, good and completely healing) in PRG group is better than conventional group(u=- 3.081, P 0.05). During the observation period, there was no serious adverse events associated with PRG treatment. Conclusions PRG treatment is effective, safe in treating the refractory diabetic foot ulcers, and significantly promotes ulcer healing without increasing economic burden in hospital. Key words: Platelet–rich gel; Diabetic foot; Refractory diabetic foot ulcer; Randomized controlled study