Effectiveness of Calendula Officinalis Extract Cream versus Silver Sulfadiazine Cream on Ulcer Healing in Patients with Pressure Ulcers: A Pilot Randomized Controlled Trial

Abstract

Objective: To compare the efficacy and safety of 5% Calendula officinalis extract cream with 1% silver sulfadiazine cream in the treatment of pressure ulcers. Methods: This pilot randomized controlled trial recruited 44 patients with pressure ulcers who were randomly assigned to receive either Calendula officinalis extract cream (n=24) or silver sulfadiazine cream (n=20). The primary outcome was change of the Pressure Ulcer Scale for Healing (PUSH) scores over a 10-week follow-up period. The study analyzed repeatedly measured variables using a Linear Mixed-Effects Model (LMM), adjusting for baseline values and relevant covariates. The proportion of ulcers healed at 10 weeks was compared using Chi-square test. Safety was assessed by monitoring the incidence of adverse events (AEs), serious adverse events (SAEs), and treatment-emergent adverse events (TEAEs). Results: Baseline characteristics were comparable between the two groups. LMM analysis demonstrated that from weeks 6–10, the Calendula officinalis group showed a greater reduction in PUSH scores, with statistically significant differences at weeks 9 and 10 (Least square mean difference 1.90, P=0.02 and 2.03, P=0.01, respectively). The proportion of ulcers healed at 10 weeks did not differ significantly between groups (P=0.10). No AEs, SAEs, or TEAEs were observed in either group. Conclusion: The 5% Calendula officinalis extract cream showed a greater reduction in PUSH scores at weeks 9–10 compared with silver sulfadiazine, without observed adverse events. However, no statistically significant differences were found in the proportion of ulcers healed. These findings suggest that Calendula officinalis may have potential in promoting wound healing, but its definitive clinical efficacy has not yet been established. Further large-scale studies are warranted.