Game F, Gray K, Chokkalingam K, et al. Int Wound J. 2021;18:692-700
Objective:
This pilot study aimed to determine if adding a dried human amnion membrane (dHAM) product to standard care would improve the healing rate of diabetic foot ulcers (DFUs) compared to standard care alone.
Study Design:
A multicenter, prospective, patient- and observer-blind randomized controlled trial was conducted. Thirty-one patients were randomized to either receive dHAM with standard care (n=15) or standard care alone (n=16). The study measured the proportion of ulcers healed within 12 weeks as the primary outcome, with secondary outcomes including time to healing, percentage wound area reduction, and adverse events.
Results:
After 12 weeks, 27% of ulcers in the dHAM group healed compared to 6.3% in the standard care group, although this difference was not statistically significant. However, the dHAM group showed significantly greater wound area reduction (p=0.0014). No significant differences were found in terms of adverse events, indicating a comparable safety profile.
Conclusion:
The addition of dHAM to standard care shows promise for improving wound healing rates and reducing wound area in diabetic foot ulcers. The findings support the need for further trials with larger sample sizes.
Link to Article:
The Effectiveness of a New Dried Human Amnion Derived Membrane in Treating Diabetic Foot Ulcers