Authors: Aliquò MS, Sabatino G, Serio AM, Favuzza L, Corrao S.
Introduction: Diabetic foot ulcers are rapidly becoming a social problem and a severe drain of health resources due to the current worldwide diabetes epidemic. A gel formulation of natural-origin polynucleotides (PN HPT™, Polynucleotides Highly Purified Technology) and hyaluronic acid in a topical medical device (NUCLIASKIN S, Mastelli S.r.l., Sanremo, Italy) was designed explicitly for wound bed management and extensively employed. The medical device has activating properties on dermal fibroblasts thanks to the passive replenishment of tissue reservoirs of purines, pyrimidines, nucleotides and nucleosides while preserving the ideal moist wound bed environment. The study aimed to confirm the topical medical device’s long-term effectiveness and safety profile within a multi-year efficacy and safety monitoring program.
Methods: Retrospective comparison, in 124 patients with diabetic foot ulcers, between the usual high-quality standard of care (weekly wound cleansing and disinfection, debridement with scalpel and curette, and secondary sterile dressing) and the usual standard of care plus add-on NUCLIASKIN S gel treatment every three to six days according to the medical device’s information leaflet. The primary efficacy parameter in the two retrospective cohorts was complete healing after 12 and 24 weeks; the secondary efficacy parameter was healing time.
Results: Compared with controls who received only the routine standard of care, the proportion of complete wound closure after 12 and 24 weeks in patients was significantly higher in the add-on cohort. Time to complete healing in the Nucliaskin S-treated cohort diverged from controls after 60 days, with significantly higher healing rates after 90 days—64% of Nucliaskin S-treated patients vs 38% of controls. There were no reports of allergic or other adverse events.
Conclusions: The study demonstrated that NUCLIASKIN S retains its long-standing record of excellent handiness, safety, and efficient and superior performance in facilitating the healing of the diabetic foot, a clinically troublesome and labour-intensive condition for healthcare providers, even compared to the highest-quality standard of care.
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