Efficacy of a full-thickness decellularised placental membrane allograft compared to standard of care in diabetic foot ulcers: a prospective, randomised controlled trial
Summary: Multicentre RCT comparing FT-DPM adjunct to standard care versus standard care alone in persistent DFUs. FT-DPM showed higher 12-week closure and greater percentage area reduction, with fewer serious adverse events.
Key Highlights:
- Design: Eight-site RCT; all wounds offloaded and debrided.
- Outcomes: 12-week closure 48% vs 27% (per protocol); area reduction ~79% vs 56%.
- Safety: Fewer serious AEs in FT-DPM group; none treatment-related.
Keywords:
Reyzelman,
Vayser,
Hanft,
Cazzell,
placental membrane,
DFU,
randomised controlled trial