Human amniotic membrane extract for the management of diabetic foot ulcers: a randomised comparative study.

Previous studies by the authors have shown that human amniotic membrane extract (AME) potentially improves epithelial damage in corneal and skin lesions. However, questions about its role in diabetic foot ulcer (DFU) treatment remain unanswered. In this study, patients with hard-to-heal DFUs were randomly selected after screening and, after confirming the safety of the AME in an initial selection of patients, the remaining participants were divided into two groups. The treatment group received an AME product (DiAMX, Royan Stem Cell Technology, Iran) (concentration 1mg/ml) with standard of care (SoC), topically, every 48 hours for the first week and then every 72 hours until complete closure. The control group received SoC. Patients were visited weekly, and any improvement, reduction in the wound area and any side-effects were recorded. The results of the safety phase (without the control group) showed that the AME had no adverse events. In the efficacy phase, there was no significant difference in baseline characteristics between the treatment and control groups. The results showed that the wound healing rate was 100% in the treatment group and 77.5±3.12% in the control group (p<0.0001) at week 6. All wounds (n=15) were closed in the treatment group and seven wounds had closed in the control group (p<0.0001). The findings of this study showed that the topical use of DiAMX, in addition to SoC, was patient-friendly, inexpensive, safe and effective in healing hard-to-heal DFUs.