Pilot clinical trial, randomized, parallel group, blind controlled with conventional treatment to evaluate the effectiveness of plasma rich in growth factors in the treatment of skin ulcers: results at 4 weeks follow-up

INTRODUCTION: The plasma rich in growth factors (PRGF) obtained controlled centrifugation of a sample of the patient's own plasma may serve as stromal and facilitate the migration of cells involved in regeneration and have a role in the treatment of ulcers skin. The objective of this trial is to evaluate the efficacy and safety of the use of autologous plasma rich in growth factors in the treatment of ulcerative lesions. MATERIAL AND METHODS: Of the 16 patients initially calculated, finally analyzed 14 (7 men and 7 women), aged between 23 and 76 years (mean ± 53,29 +20,15), assessing 14 ulcers (29 % pressure, 64% venous and 7% other) in a pilot clinical trial, randomized, parallel group, blinded and controlled with conventional therapy. Each patient underwent a preliminary assessment of the wound, then proceeding to the measurement of the variables being tested at baseline and the application of PRGF or conventional treatment (cleaning, debridement and saline wet cure with sterile gauze as the only secondary dressings) as randomization table. Patients attended once a week for four weeks for consultation to assess the state of the injury and proceed to the application of the treatment. Treatment response was assessed by the photographic record of the wound and subsequent analysis of the performance of the test variables: percentage of recovered area and lesion area (calculated using the software Mouseyes). The PRGF was obtained in each case by extracting 20 cc of blood a few minutes before starting the treatment, using venojet tubes 4.5 cc. with 3.8% sodium citrate as anticoagulant. Then centrifuged at 1800rpm for 8 minutes at room temperature in a centrifuge model system ® PRGF (BTI Biotechnology Institute SL). The plasma thus obtained was separated into fractions by pipetting. Once plasma fractions obtained, we proceeded to activate each fraction obtained by adding 50 microliters of 10% calcium chloride per cc. of the same. For statistical evaluation of the results obtained were used nonparametric tests of Mann-Whitney and Wilcoxon. RESULTS: At baseline, both treatment groups were comparable. At four weeks, the percentage of recovered surface treated with PRGF group (59.08 ± 23.89%) is significantly higher (p <0.01) in the control group (3.05 ± 35.30%). When comparing the evolution in each group, in the group treated with PRGF shows a significant decrease (p <0.05) compared to the initial area (5.21 ± 5.01 to 2.13 ± 1.89; cm2), while the control group displayed no change significantly (9.07 ± 8.37 to 8.74 ± 8.82 cm2). DISCUSSION AND CONCLUSIONS: Despite the small sample size, because this is a pilot study and in the absence of new confirmatory clinical trials with a larger number of patients, the results presented here suggest the effectiveness of plasma rich in growth factors