Objective: The efficacy of available wound dressings in the treatment of hard-to-heal wounds is limited. A new therapeutic approach using an acid-oxidising solution (AOS) was developed. Its effect on healing progress, tolerability and safety properties were investigated in a clinical study, and compared with standard of care (SOC) wound dressings. The study aimed to demonstrate the non-inferiority of AOS to SOC in terms of wound healing progress.
Method: This open-label, randomised controlled trial was conducted at two study centres in Austria with patients with either infected or non-infected hard-to-heal leg ulcers of different aetiology. Patients were treated for six weeks either with AOS or SOC wound dressings. Outcome assessments included the percentage of granulation and re-epithelialisation tissue, wound size reduction, changes in wound pH, infection control and wound pain, local tolerability and adverse events (AEs). Healing time and rate were also assessed.
Results: A total of 50 patients took part. In the AOS group, wounds exhibited higher amounts of granulation and re-epithelialisation tissue, and a faster and more pronounced wound size reduction compared with wounds in the SOC group. In the AOS-treated versus SOC-treated patients, a greater percentage of complete healing of hard-to-heal ulcers was achieved by the end of the study period (32% versus 8%, respectively). Furthermore, the wound pH decreased significantly faster in these wounds (p<0.0001). In all patients with infected leg ulcers, local infection was overcome more rapidly under AOS treatment. In the AOS group, one AE and no serious adverse events (SAEs) were detected versus 24 AEs and two SAEs in the SOC group.
Conclusion: In this study, AOS proved to be a highly effective treatment to support wound healing in infected or non-infected hard-to-heal leg ulcers of different aetiology. Efficacy was found to be not only non-inferior but superior to SOC wound dressings. Furthermore, tolerability and safety profiles were favourable for AOS.
Keywords: AOS; DFU; Nexodyn; SOC; acid-oxidising solution; adverse events; chronic; diabetes; diabetic; dressing; dressings; foot ulcers; hard-to-heal; healing; leg ulcers; standard of care; tolerability; ulcers; wound; wound care; wound dressing; wound healing; wound microenvironment.