Abstract
Most chronic wounds are related to comorbidities, for which no clinical trials are performed. This retrospective propensity matched-cohort study examined data from 2 074 000 lower extremity wounds across 644 institutions to determine the effectiveness of TheraSkin plus standard of care (SOC; n = 1997) versus SOC alone (n = 1997). Multivariate modelling comparing outcomes such as healing rates, percent area reductions (PARs), amputations, recidivism, treatment completion, and medical transfers were evaluated. A higher proportion of wounds in the treatment group compared with the controls were more likely to close (68.3% versus 60.3%), particularly wounds with exposed structures (64% versus 50.4%) and with lower recidivism at 6 months (24.9% versus 28.3%). The control group was 2.75x more likely to require amputation than the treatment group. The combination of propensity matching and logistic regression analysis on a particularly large database demonstrated that wounds treated with TheraSkin had higher healing rates, higher PARs (78.7% versus 68.9%), fewer amputations, lower recidivism, higher treatment completion (61.0% versus 50.6%), and lower medical transfers (16.1% versus 23.5%) than SOC alone. This study considered data from complex wounds typically excluded from controlled trials and supports the idea that real-world evidence studies can be valid and reliable.