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.
Reyzelman et al. (Tue,) studied this question.