Effectiveness of viable cryopreserved placental membranes for management of diabetic foot ulcers in a real world setting

Abstract

In a multicenter randomized controlled trial (RCT), the use of viable cryopreserved placental membrane (vCPM) for chronic diabetic foot ulcers (DFUs) resulted in a higher proportion of wound closure in comparison to good wound care: 62% versus 21% (p < 0.01). However, patients in RCTs are not representative of daily physician practice. Healthcare databases serve as a valuable tool to evaluate therapy effectiveness and to supplement evidence from RCTs. The objective of this study was to evaluate the effectiveness of vCPM for DFU management using Net Health's WoundExpert® electronic health records (EHR). The primary endpoint was the proportion of DFUs that achieved complete closure. Other endpoints included time and number of grafts to closure, probability of wound closure by week 12, and the number of wound-related infections and amputations. De-identified EHR data for 360 patients with 441 wounds treated with vCPM were extracted from the database. Average patient age was 63.7 years with a mean wound size of 5.1 cm² and an average wound duration of 102 days prior to vCPM treatment. For evaluation of clinical outcomes, 350 DFUs larger than 0.25 cm² at baseline were analyzed. Closure at the end of treatment was achieved in 59.4% of wounds with a median treatment duration of 42.0 days and 4 applications of vCPM. The probability of wound closure at week 12 was 71%, and the number of amputations and wound-related infections was 13 (3.0%) and 9 (2.0%), respectively. Data also demonstrated a correlation between wound size and closure rate as well as a correlation between > 50% wound area reduction by week 4 and wound closure by week 12. The results of this study mirror previous RCT efficacy data, supporting the benefits of vCPM for DFU management. These results can also influence policy and treatment decisions regarding advanced vCPM technology.