Journal of wound care · 2025
Efficacy and safety of a medical device based on hyaluronic acid and amino acids for the topical treatment of hard-to-heal skin ulcers: a pilot clinical trial.
СтатьяМногоцентровое исследованиеКлиническое исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Romanelli Marco, Michelucci Alessandra, Reggiardo Giorgio, Saponati Giorgio, Cassino Roberto
Аннотация
OBJECTIVE: Wound healing is a complex process involving haemostasis, inflammation, proliferation and remodelling. Dysregulation in any phase impairs healing. Hyaluronic acid (HA) and amino acids are essential in promoting tissue repair. This study evaluated a topical medical device containing HA and amino acids for its safety and efficacy in treating hard-to-heal (chronic) wounds.
METHOD: This four-week, one-arm, two-centre pilot clinical study included patients with hard-to-heal wounds of various aetiologies. Wounds were classified by exudate level and amount of necrosis. Treatment with different vehicles (cream, gel or powder) was tailored based on wound characteristics. Wound size was measured at baseline and final visit, while symptom severity was tracked using the total symptom score (TSS). Investigator assessment and safety monitoring were also conducted.
RESULTS: A total of 60 patients were included in the study. Wound size reduced significantly across all groups, with an average reduction of 54%, and 41% of patients achieving complete healing. Symptom severity, as measured by TSS, showed a consistent and significant reduction. Clinical improvement was observed in 95% of patients and no serious adverse events were reported. The product demonstrated good safety and tolerability.
CONCLUSION: In this study, the HA and amino acids product effectively reduced ulcer size, improved symptoms and promoted healing, demonstrating its efficacy in hard-to-heal wound management. The findings are clinically significant but limited by the absence of a control group and a short observation period. Further randomised controlled trials are required to confirm these results and explore broader clinical applications.
METHOD: This four-week, one-arm, two-centre pilot clinical study included patients with hard-to-heal wounds of various aetiologies. Wounds were classified by exudate level and amount of necrosis. Treatment with different vehicles (cream, gel or powder) was tailored based on wound characteristics. Wound size was measured at baseline and final visit, while symptom severity was tracked using the total symptom score (TSS). Investigator assessment and safety monitoring were also conducted.
RESULTS: A total of 60 patients were included in the study. Wound size reduced significantly across all groups, with an average reduction of 54%, and 41% of patients achieving complete healing. Symptom severity, as measured by TSS, showed a consistent and significant reduction. Clinical improvement was observed in 95% of patients and no serious adverse events were reported. The product demonstrated good safety and tolerability.
CONCLUSION: In this study, the HA and amino acids product effectively reduced ulcer size, improved symptoms and promoted healing, demonstrating its efficacy in hard-to-heal wound management. The findings are clinically significant but limited by the absence of a control group and a short observation period. Further randomised controlled trials are required to confirm these results and explore broader clinical applications.