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Войти в исследования Journal of the American Academy of Dermatology · 2026
Physiological-concentration platelet fibrin plasma vs supraphysiological-concentration platelet rich plasma for neuro-ischemic diabetic foot ulcer and other diabetic wounds: A randomized controlled trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Li Yunfeng, Zhang Jiwei, Yang Zhiwen, Zhang Hua, Zhao Jinghui, Chen Ling, Hu Bo, Wang Wenhui, Tie Lu, Zhang Long
Аннотация
BACKGROUND: Although platelet concentrates are associated with substantial blood consumption, whether platelet products at physiological concentrations can achieve comparable efficacy in chronic wounds remains unclear.
OBJECTIVE: To determine if physiological concentration platelet fibrin plasma (PFP) is noninferior to supraphysiological platelet-rich plasma (PRP) for diabetic wound healing.
METHODS: This single-center, noninferior 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.
RESULTS: Fifty six patients were enrolled (DFU: 66%, all neuro-ischemic type; other sites: 34%), groups were balanced (DFU: 65.5% vs 64.3%, P = .922). Noninferiority was confirmed: 4-week healing was 78.6% (PFP) vs 71.4% (PRP) (1-sided 95% CI lower bound -12.4%, P = .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 > .05).
LIMITATIONS: Single center with a relatively small sample size.
CONCLUSION: Physiological PFP demonstrated similar efficacy to supraphysiological PRP. With simpler preparation and lower blood consumption, PFP offers a practical, equivalent alternative.
OBJECTIVE: To determine if physiological concentration platelet fibrin plasma (PFP) is noninferior to supraphysiological platelet-rich plasma (PRP) for diabetic wound healing.
METHODS: This single-center, noninferior 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.
RESULTS: Fifty six patients were enrolled (DFU: 66%, all neuro-ischemic type; other sites: 34%), groups were balanced (DFU: 65.5% vs 64.3%, P = .922). Noninferiority was confirmed: 4-week healing was 78.6% (PFP) vs 71.4% (PRP) (1-sided 95% CI lower bound -12.4%, P = .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 > .05).
LIMITATIONS: Single center with a relatively small sample size.
CONCLUSION: Physiological PFP demonstrated similar efficacy to supraphysiological PRP. With simpler preparation and lower blood consumption, PFP offers a practical, equivalent alternative.