Meta-analysis of cellular and acellular tissue-based products demonstrates improvement of diabetic foot ulcer healing despite age and wound size

Background: Patients with diabetes are at an increased risk of developing chronic adverse events owing to diabetes-associated complications. Diabetic foot ulcers (DFUs) occur in approximately 15% of all diabetic patients. Patients with larger wound sizes and increasing age are often excluded from clinical trials. Methods: A meta-analysis to compare the complete wound healing rates of patients receiving cellular and acellular matrix products (CAMPs) with standard of care (SOC) and with SOC alone was conducted. A total of 29 randomized controlled trials involving 2255 patients with DFU were included in the meta-analysis. Results: The results indicated that the complete healing rate for CAMPs plus SOC patients was higher than for patients receiving SOC only. The aggregated odds ratio is 2.9 (95% confidence interval, 2.3-3.8). Patients in the CAMPs plus SOC group were almost three times more likely to achieve 100% wound closure than those treated with SOC only through final follow-up in each study. The median follow-up duration across studies was 12 weeks (Q1-Q3: 12-16 weeks), with no significant differences in follow-up length between the two arms. Conclusions: Patients receiving CAMPs for DFUs were more likely to achieve wound closure. Meta-regression analysis of the moderators indicated that both moderators, average patient age and average wound size (baseline), displayed a nonsignificant relationship to the main outcome of wound closure. These findings suggest that patient age and wound size should not be excluded from clinical trials.