Objective: The records from a network of mobile wound clinics were analyzed to evaluate the efficacy of a human placental-based allograft compared with the standard of care for patients with chronic pressure ulcer wounds and multiple comorbidities. Approach: Real-world evidence from a mobile wound clinic (July 2022–June 2023) was used to analyze patients with pressure ulcer wounds, most of whom received home-based wound care and had multiple comorbidities that worsened their chronic wounds. Patients were grouped into standard of care with debridement or standard of care with debridement and grafting intervention. After each visit, the wound area and depth were measured and recorded. Wounds were scored for granulation and epithelialization and eschar and slough during each visit. The standard of care with debridement and grafting cohort was monitored for graft duration, and the number of graft applications per wound was recorded. Statistical analysis used a paired t -test and ANOVA for multiple comparisons. Results: The standard of care with debridement and grafting cohort demonstrated an average percent change in wound area of 46% reduction, compared to a 42% increase in the standard of care ( p < 0.001). The mean percent change in wound depth was a 36% reduction in the graft recipients versus a 37% increase in the standard of care with debridement ( p < 0.001). Graft recipients improved their positive wound score by 8% (granulation and epithelialization), and decreased their negative wound score decreased by 55% (eschar and slough) after the final graft visit, compared with patients receiving standard of care with debridement. The average duration of the graft was 147 days (±8 days), involving 22 applications (±1.7) per wound. Conclusion: We present real-world evidence demonstrating the use of placental-based grafts to reduce wound size in patients with chronic PU, multiple comorbidities and limited mobility. Our study highlights the importance of reviewing the current local coverage determination and making graft applications permissible based on patients’ wound-care responses, thereby benefiting patient care and quality of life.
Kay et al. (2026) studied this question.