Physiological-concentration Platelet Fibrin Plasma vs. Supra-Physiological-concentration Platelet Rich Plasma for Neuro-ischemic Diabetic Foot Ulcer and other Diabetic Wounds: A Randomized Controlled Trial.

Abstract

Although platelet concentrates are associated with substantial blood consumption, whether platelet products at physiological concentrations can achieve comparable efficacy in chronic wounds remains unclear. To determine if physiological concentration platelet fibrin plasma (PFP) is non-inferior to supra-physiological platelet-rich plasma (PRP) for diabetic wound healing. This single-center, non-inferior randomized controlled trial enrolled patients with diabetic wounds who, after wound-bed-preparation with corrected infection, ischemia, stasis, shear forces, were scheduled for debridement suture surgery (DSS). Participants received either PFP (1× baseline) or PRP (4× baseline) during DSS. The primary outcome was the 4-week healing rate. Subgroup analysis was based on ulcer location. 56 patients were enrolled (DFU: 66%, all neuro-ischemic type; other sites: 34%), groups were balanced (DFU: 65.5% vs 64.3%, P=0.922;). Non-inferiority was confirmed: 4-week healing was 78.6% (PFP) vs 71.4% (PRP) (one-sided 95% CI lower bound -12.4%, P=0.038). No significant differences emerged in 2-, 3-, 6-, and 8-week healing rates, mean healing time (30.1 vs 32.2 days) (all P>0.05). Single center with a relatively small sample size. Physiological PFP demonstrated similar efficacy to supra-physiological PRP. With simpler preparation and lower blood consumption, PFP offers a practical, equivalent alternative.