ABSTRACT
OBJECTIVE: The treatment of patients with hard-to-heal wounds represents a major multidisciplinary challenge. Therefore, the development and clinical validation of new technologies remains extremely important. The novel application of concurrent optical and magnetic stimulation (COMS) offers a promising noninvasive approach to support physiological wound healing processes, especially in hard-to-heal wounds. METHOD: In a multicentre, prospective, comparative, clinical trial, patients with hard-to-heal wounds on lower extremities of different aetiologies were treated with COMS as an adjunct to standard of care (SOC). The primary endpoint was safety; secondary endpoints were wound healing, pain and wound-specific quality of life (Wound-QoL). RESULTS: A total of 40 patients were enrolled in this study (intention to treat population (ITTP), n=40). Of these patients, 37 were included in the analysis of the primary endpoint (primary endpoint population, (PEP), n=37). A further subgroup of 30 patients was included in the analysis of the secondary endpoint (secondary endpoint population (SEP), n=30). Finally, the SEP was stratified regarding patients' responsiveness to SOC in an SOC non-responder subgroup (NRSG), n=21, and in an SOC responder subgroup (RSG), n=9. A total of 102 adverse events (AEs) were recorded, of which 96% were 'mild' or 'moderate', and 91% were either a singular or transient event. Only 11 AEs were serious and associated with inpatient treatments unrelated to the studied intervention. In the NRSG, reductions in wound size were found to be statistically significant within the different study periods. Additionally, an acceleration of the healing rate was detected between the baseline and the first four weeks of COMS treatment (p=0.041). The rate of near-complete and complete wound closure in the SEP after 12 weeks were 60% and 43%, respectively. Pain reduction across the treatment group was statistically significant (p≤0.002 for both the SEP and NRSG). The Wound-QoL score improved by 24% during the study (p=0.001). CONCLUSION: In this study, COMS treatment for patients with hard-to-heal wounds on lower extremities was a safe and effective novel treatment option, especially for patients who did not respond to SOC.
