Study Protocol: Autologous Platelet-Rich Plasma (PRP) Therapy in the Treatment of Pyoderma Gangrenosum: A Prospective, Open-Label, Randomized, Split-Ulcer Trial to Evaluate the Efficacy of Platelet-Rich Plasma Therapy in the Treatment of Chronic Pyoderma Gangrenosum

Abstract

BACKGROUND Pyoderma gangrenosum (PG) presents as an ulceration of the lower extremities with deep, undermining, and violaceous borders. The disease is an orphan disease without any FDA-approved treatments. OBJECTIVE This study aims to evaluate the efficacy and safety of intralesional injectable and topical platelet-rich plasma (PRP) therapy in the treatment of chronic pyoderma gangrenosum ulcerations. METHODS Methodologically, this study will be conducted as a prospective, randomized, open-label split-ulcer study in patients with confirmed PG by PARACELSUS score. In each patient, up to three separate ulcerations will be randomized to receive either monthly intralesional PRP injections or a topical PRP solution at 0, 4, 8, and 12 weeks, while the third target lesion will receive standard wound care only. Patients will be followed up with at 16 weeks, one month after the completion of treatment. The primary endpoint for this study will be the composite proportion of the target ulcers achieving either complete resolution or a 50% reduction in the surface area at week 12. CONCLUSIONS This study intends to demonstrate the efficacy of an intralesional injectable or topical PRP therapy in the treatment of PG. If successful, PRP treatment may offer a new and effective option for patients with this debilitating disease.