Efficacy And Safety Of Allogeneic Platelet Rich Plasma In Treatment Of Diabetic Patients With Lower Limbs Ulcer:A Pilot Study

BACKGROUND:Autologous platelet rich plasma(au-PRP)has been widely used for management of refractory chronic wounds with an achieved good results in the fields of orthopedics,burns,endocrinology and plastic surgery.However,in clinical practice,if patients with diabetes have malnutrition,severe immune dysfunction,thrombocytopenia or severe acute and chronic diseases,the ultility of au-PRP is limited.In order to overcome these limitations,the use of allogeneic platelet-rich plasma(al-PRP)in the treatment of diabetic lower extremity ulcers is worthy of further investigation.OBJECTIVE:To observe the feasibility,efficacy and safety of al-PRP in the treatment of diabetic lower extremity ulcers.Furthermore,to explore the difference between au-PRP treatment,al-PRP treatment and only conventional treatment groups.METHODS:A total of 75 inpatients with type 2 diabetes from December 2015 to August 2018 in our hospital were divided into au-PRP group(n=20),al-PRP group(n=25),conventional treatment control group(NC group,n=30).All three groups were administered basic diabetic treatments including lowering blood sugar,controlling blood pressure,regulating blood lipids,anti-infection and improving peripheral microcirculation and nerve function.After then,the above three different treatment methods were given.The feasibility,curative effect and safety of au-PRP in the treatment of diabetic lower extremity ulcer were evaluated by observing wound healing time,the average daily healing area and adverse reactions.RESULTS:No significant differences were observed in duration of diabetes,age,glycosylated hemoglobin,ankle brachial index,transcutaneous oxygen partial pressure,high-sensitivity C-reactive protein,IL-6,etc.among the three groups(P>0.05).There were no significant differences in complication of heart disease,hypertension,cerebral infarction,diabetic nephropathy,diabetic peripheral vascular disease,diabetic retinopathy,hyperlipidemia,smoking history(P>0.05).There was no significant difference in ulcer area and ulcer number between the three groups(8.43±6.93 cm~2 vs 5.64±3.91 cm~2 vs 9.73±9.72 cm~2,P=0.19);The times of platelet-rich plasma(PRP)treatment and average PRP platelet concentration between au-PRP group and al-PRP group have no significant difference(P>0.05).In the healing time,the al-PRP group and the au-PRP group were significantly shorter than the control group(56.9±29.22 days vs 55.6±33.8 days vs 88.0±43.4 days,P<0.01),while there was no significant difference between the al-PRP group and the au-PRP group(P>0.05).There was no significant difference in the average daily healing area(mm~2)between the three groups(P>0.05).No significant adverse reactions(infection,itchy skin,redness,rash,etc.)were observed in the au-PRP group and the al-PRP group.CONCLUSIONS:Al-PRP can effectively and safely promote the healing of diabetic lower extremity wounds.Al-PRP can be used as a beneficial cell therapy supplement when au-PRP is limited.However,a larger sample of randomized controlled trials is needed to further determine its benefit in the future.