Effectiveness of autologous platelet-rich plasma dressing in healing chronic diabetic foot ulcers in comparison with saline dressing. A randomized control study

Abstract

Background: Diabetes mellitus is one of the common metabolic disorders that have high morbidity. Diabetic patients are prone to developing chronic nonhealing foot ulcers, a leading cause of limb amputations. Autologous platelet-rich plasma (PRP) contains proteins rich in multiple growth factors (GFs) used in treating chronic diabetic foot ulcers and helps in early tissue repair and regeneration. This study aimed to evaluate the safety and enhanced efficacy of autologous PRP, in the healing rate of chronic diabetic foot ulcers. Methodology: This was a randomized control open clinical study of 18-month duration involving 50 patients in each group. Patients admitted with type 2 diabetes mellitus–with hemoglobin A1c >6.5 and chronic healing long-standing ulcer of >1-month duration were included. Patients with severe anemia and cardiac illness, osteomyelitis were excluded as they are independent risk factors that affect ulcer healing. Admitted patients were randomly allocated to receive either PRP or normal saline dressings using computer-generated random numbers. Simple debridement was done to remove necrotic tissue on the day of admission before the first application of PRP or normal saline dressing. PRP was prepared after centrifugation of autologous whole blood (10 ml). In the study group, prepared and stored PRP (1–2 ml) was applied topically in drops using a syringe to cover the floor of the ulcer and covered with a sterile transparent dressing. In the control group, normal saline was soaked in the gauze and kept over the surface of the ulcer covered with a transparent dressing. The patient will receive dressings with PRP or saline according to the group they were placed in. Progress was monitored, and the dressing was changed every 3rd day for up to 21 days. The wound area measurement was done by measuring the surface area of the wound with the help of a transparent sheet and graph. A transparent sheet was placed on the ulcer, and the total area of the ulcer was marked and recorded. The marked transparent sheet was placed over a graph sheet, and the outline was plotted. The area was calculated and recorded in cm2. The growth and healing of the wound are considered when a part of the wound shows an increase in granulation and a decrease in slough. Periodic photographs were taken on day 3, day 7, day 14, and day 21 and assessed. Two groups were compared for wound size reduction and duration of healing. The collected data were entered in Excel 2010 and measured using mean and standard deviation for continuous variables and in percentage for dichotomous and categorical variables. Two groups were compared using an independent t-test for continuous variables and a Chi-square test for dichotomous and categorical variables. Results: In our study on 100 patients, 50 in each group with ulcers of Wagner's Grade 1 and Grade 2, the appearance of granulation and size reduction rate is delayed with normal saline dressing (44/50 patients [88%]). In the autologous PRP dressing group, the rate of granulation from the 7th day of dressing was greater (50/50, patients [100%]) and ulcer size reduction is statistically significant (Chi-square value 6.38, P < 0.001) when compared to normal saline. Conclusions: Autologous PRP used in chronic diabetic foot ulcer dressing enhances healing and shows a significant reduction in wound size over a shorter duration when compared with saline dressing. Autologous PRP is safe, efficient, and simple to prepare, providing necessary GFs to improve healing without adverse events.