Effectiveness of Human Cellular Umbilical Tissue Allograft Compared to Acellular Matrix Products in Managing Diabetic Lower Extremity Ulcers in Hospitalized Patients

Background: CAMPs (cellular and acellular matrix products) can facilitate wound closure and improve clinical outcomes in patients with diabetic lower extremity ulcers (DLEU), however, there is a lack of comparative data between different CAMPs. The objective of this study was to use real-world evidence to compare the clinical and economic outcomes of hospital care for DLEU patients treated with a minimally manipulated human umbilical tissue (STRAVIX{lozenge}) or other acellular CAMPs. Methods: This retrospective analysis was conducted on patients with DLEU treated with the CAMPs using data from the Premier PINC AI Healthcare Database. Each patient's earliest inpatient encounter was designated as the index admission. The analysis groups included a cellular human umbilical tissue allograft (STRAVIX) and four different acellular CAMPs (aCAMPs). To balance baseline covariates, inverse probability of treatment weighting (IPTW) was applied. Subsequently, IPTW-adjusted generalized linear models were utilized to estimate healthcare-related outcomes and hospital-related costs. Results: 2,626 DLEUs patients with STRAVIX and 10,002 DLEUs patients with aCAMPs were identified. Compared to the patients treated with aCAMPs, the patients who had STRAVIX in addition to standard of care had significantly lower odds of having an infection reaction, dehiscence, minor and major amputations, after index admission discharge. The number of DLEU related follow-up visits was 17-23% lower, debridement related visits were 19-23% lower and the incidence of all-cause readmission was 22-25% lower in Stravix patients compared to aCAMP patients. The length of hospital stay days was 3% lower and the cost of all-cause visits was 20-25% lower in STRAVIX treated patients compared to aCAMP patients. Conclusion: This large data set demonstrates improved clinical outcomes in patients who had STRAVIX in addition to standard surgical management, when compared to certain acellular CAMPs.