Summary:
This prospective, randomized, multicenter trial, conducted by Snyder RJ, Shimozaki K, Tallis A, and colleagues, examines the efficacy of using dehydrated amniotic membrane allograft (DAMA) in conjunction with standard care (SOC) for the treatment of chronic diabetic foot ulcers (DFUs). Chronic DFUs are a common complication in diabetic patients, posing significant risks such as amputation. The study compares DAMA plus SOC to SOC alone to determine its effectiveness in promoting wound closure.
Objective:
The primary goal of the study was to compare the wound closure rates and safety profile of DAMA plus SOC versus SOC alone in patients with chronic DFUs.
Study Design:
This open-label, parallel group trial, conducted across eight clinical sites in the United States, involved 29 participants randomized into two groups: DAMA+SOC (n=15) and SOC alone (n=14). The study duration was 6 weeks, during which the complete wound closure rates were assessed.
Results:
The results showed that 33% of participants in the DAMA+SOC group achieved complete wound closure by week 6, compared to 0% in the SOC group (p=0.017). DAMA significantly accelerated wound healing as demonstrated by the Kaplan-Meier analysis (p<0.0001). The study found no significant differences in adverse events between the groups, indicating that DAMA is a safe option for treating chronic DFUs.
Conclusion:
The study concludes that DAMA, when used in addition to standard care, significantly improves wound closure rates in chronic DFUs, making it an effective and safe treatment option. However, the small sample size and open-label design are limitations, and further research is recommended to confirm these findings.
For more details, refer to the original article:
Snyder RJ, Shimozaki K, Tallis A, et al. A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcers. Wounds. 2016;28(3):70-77.