Wounds Regeneration 4.0. efficacy in the managing of cutaneous lesions with a new medical device: Lecoxen® Cream.

Background: This work summarizes the technical and scientific advancements in wound repair and regeneration, building on concepts from the authors' previous publications. The application of the anti-inflammatory and regenerative medicine (AIMED) method is analyzed, introducing a new therapeutic approach for patients using a medical device, Lecoxen cream.

Methods: A diagnostic and therapeutic pathway for patients with acute, chronic, and recalcitrant skin lesions was implemented at two Italian medical centers. The AIMED method, focusing on reducing inflammation and promoting regeneration, was used. In the retrospective observational study, patients were randomized into two groups with a 1:1 ratio, with Group A receiving Lecoxen cream to assess its efficacy.

Results: Wound healing progress was assessed at 12 and 24 weeks, with patients stratified based on the cause of the lesion. Included patients had vascular lesions, pressure ulcers, diabetic foot ulcers, rare-origin lesions, acute or traumatic wounds, surgical complications, and burns. At 24 weeks, a significantly higher complete recovery was observed in patients with vascular lesions treated with Lecoxen compared to the control group. Additionally, pain reduction measured using the VAS Scale showed a 100% reduction in pain after 4 weeks of treatment in the Lecoxen group compared to the control.

Conclusions: This retrospective study has validated a multidisciplinary approach to chronic wound treatment, centered on the use of Lecoxen. The device's functionalities were integrated into the therapeutic approach; by correlating clinical data with biochemical and cellular parameters, the study demonstrated the device's role in tissue repair and regeneration, providing a foundation for future research.