Case series to evaluate the Omeza® Combination Therapy in the treatment of lower extremity ulcers of mixed etiologies exhibiting bacterial contamination as determined by a novel violet-light camera system and correlating biomarkers

Introduction: Wound healing is optimized by utilizating therapies that control bacterial burden, decrease tissue inflammation, support the extracellular matrix and establish a balanced healing environment. The Omeza® Combination Therapy (OCT) products are formulated to combat the underlying pathophysiologies contributing to wound chronicity. All products contain Omeza® oil which is an anhydrous formulation of Omega-3, 6 and 9 oils plus nutrients in a rapidly penetrating delivery system.

Objective: This pilot study evaluated the total wound area reduction in subjects treated with the OCT and tracked bacterial burden via fluorescence images and PCR cultures throughout the 12-week treatment period.

Methods: This is a single-site, open label, case series. 3 subjects > 18 years and having open wounds of the lower extremity were enrolled. All subjects signed the informed consent and successfully completed the screening visit prior to entering the study. Fluorescence and standard wound photographs and measurement were obtained weekly via a fluorescence imaging device. PCR wound cultures were obtained per protocol. Wound debridement was performed per discretion of the investigator followed by application of the OCT plus SOC dressings. Patients were seen weekly throughout the course of the study.

Results: This case series included one diabetic foot ulcer and two venous leg ulcers. The mean baseline wound age was 24 weeks with a mean baseline wound size of 8.61 cm2. The mean wound area reduction of all wounds combined was 82%. The two VLUs healed during the study period. The TWAR of the DFU was 53% at 6-weeks when the patient was lost to follow-up due to a geographic relocation. Fluorescence imaging showed clearance of pathologic levels of bacterial contamination over the course of the study for all subjects.

Conclusion: The use of OCT proved to be effective and safe. The wounds included in this study were stalled in the inflammatory stage with no signs of healing. OCT supported wound healing and reduced bacterial loads in this patient cohort.