Efficacy of a full-thickness decellularised placental membrane allograft compared to standard of care in diabetic foot ulcers: a prospective, randomised controlled trial
Summary: This multicentre, prospective, randomised controlled trial assessed the safety and efficacy of adjunctive full-thickness decellularised placental membrane (FT-DPM) compared to standard of care (SoC) for persistent and recalcitrant diabetic foot ulcers (DFUs). A total of 57 patients received FT-DPM and 51 received SoC, with all wounds debrided and offloaded. FT-DPM significantly improved wound closure and percentage area reduction at 12 weeks compared to SoC. The treatment was also associated with fewer serious adverse events, underscoring its potential as an innovative therapy for chronic DFUs.
Key Highlights:
- Design: Multicentre, prospective, randomised controlled trial conducted across eight U.S. outpatient wound clinics (2022–2024).
- Treatment protocol: FT-DPM applied to wound bed post-debridement and left in place for 5–9 days; SoC included moist wound therapy with alginates, foams, or hydrogels.
- Healing outcomes: FT-DPM group achieved 48% wound closure at 12 weeks versus 27% in SoC (p=0.0499, per-protocol analysis).
- Area reduction: Mean percentage area reduction was 79% in FT-DPM vs. 56% in SoC (p<0.05).
- Adverse events: Serious adverse events were significantly higher in SoC (29%) compared to FT-DPM (2%), none of which were treatment-related.
- Clinical relevance: Findings demonstrate FT-DPM’s structural and biological advantages over amnion-only grafts, offering improved scaffold integrity, biological factor retention, angiogenesis promotion, and host tissue integration.
- Regulatory & ethics: Approved by the WIRB-Copernicus IRB (Protocol #20215453) and registered on ClinicalTrials.gov (NCT05087758).
Read the full article in Journal of Wound Care (JWC)
Keywords:
Alexander M Reyzelman,
Dean Vayser,
Jason R Hanft,
Shawn Cazzell,
diabetic foot ulcer,
placental membrane,
DFU treatment,
clinical trial,
regenerative medicine,
decellularised allograft