Efficacy of a full-thickness decellularised placental membrane allograft compared to standard of care in diabetic foot ulcers: a prospective, randomised controlled trial

This multicentre, randomised controlled trial evaluated the efficacy and safety of adjunctive full-thickness decellularised placental membrane (FT-DPM) in treating persistent and recalcitrant diabetic foot ulcers (DFUs) compared to standard of care (SoC). A total of 57 patients were analysed in the treatment group; the study product was applied to the wound bed post debridement and left in place for 5-9 days. Some 51 patients received SoC only, including debridement and moist wound therapy with alginates, foams or hydrogels. All wounds were offloaded. The findings of this study showed that the FT-DPM significantly improved wound closure rates at 12 weeks compared to SoC (48% versus 27%, respectively; p=0.0499, per-protocol analysis), with a significant percentage area reduction (79% versus 56%, respectively; p<0.05). Mild and moderate adverse events were similar between groups, while serious adverse events were more frequent in the SoC group compared with the FT-DPM group (29% versus 2%, respectively); none were related to treatment. These findings suggest that FT-DPM is an effective and innovative treatment for hard-to-heal (chronic) DFUs, offering a superior option to SoC, particularly for wounds that resist conventional treatments. This approach has the potential to significantly improve patient outcomes and reduce the societal burden of hard-to-heal wounds.