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Clinical Research
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A prospective, randomized, controlled, blinded, multicenter pivotal trial of a platelet rich plasma* gel versus control when added to the standard of care in the treatment of non-healing diabetic foot ulcers First Author: Vickie Driver Authors: Vickie R. Driver, DPM, MS, FACFAS, Carelyn P. Fylling, RN, MSN, AutoloGel Study Group Objectives:.1. Describe the procedure for producing platelet rich plasma (PRP) gel.2. Report the safety and efficacy results of the prospective PRP gel RCT ..Methodology: A prospective, randomized, controlled, blinded, multi-center trial of PRP gel versus control for treating diabetic foot ulcers was conducted. PRP gel is an autologous, point-of-care process where a small volume of blood is drawn from the patient, centrifuged, PRP is extracted, and activated becoming a gel for topical application. The PRP gel contains multiple growth factors and a fibrin matrix scaffold. The wounds were treated twice a week for 12 weeks or until 100% epithelialization. Once healed, the wounds were followed for 3 months...Results: Seventy two (72) subjects were enrolled at 14 sites. An independent audit of sites determined that 40 subjects were protocol compliant and thus included in the per protocol analysis. The majority of these wounds (35/40) were in the size range = 7 cm2 area with volume of = 2 cm3, a size similar to other reported prospective trials. Results indicated that 81.3% of PRP gel treated wounds healed compared to 42.1% of control treated wounds (p=0.036). When larger wounds were included, 68.4% of the PRP gel healed versus 42.9% of the control treated wounds (p=0.125). There were no reported serious adverse events due to the treatment...Conclusion: This first prospective RCT in the US using autologous PRP gel for treating diabetic foot ulcers demonstrates this PRP gel is safe and efficacious for treating the majority of diabetic foot ulcers. |
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