SARASOTA — Wound care company Omeza is partnering with local physician Dr. John Yee as a sub-investigator for the company's Omeza Treatment Bundle for the treatment of chronic and complicated wounds.
According to a press release, while product development, manufacturing and its corporate headquarters have been in Sarasota since the company’s formation in 2016, most Omeza clinical trial sites to date have been located elsewhere around the country.
With Yee joining as a local sub-investigator, Omeza will be able to offer eligible patients in the area access to participate in the Expanded Indications Trial. The trial will allow investigators to preliminarily evaluate the potential effectiveness of the Omeza Treatment Bundle.
"Since our company was officially formed, we’ve regularly had inquiries from the community about participating in clinical trials," says Omeza Founder and CEO Tom Gardner in a statement. "While we are excited to have studies on-going across the country, we are also happy to have this local practice doing research in our backyard."
The study is called "An Open Label Pilot Study to Evaluate the Omeza Treatment Bundle in the Management and Treatment of Chronic Cutaneous Ulcers of Multiple Etiologies." It will take place over a period of 12 weeks per patient.
Patient indications include partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, skin tears) and draining wounds.
In December 2020, First Coast Cardio in Jacksonville became the first Florida clinical trial site for the investigation of the Omeza Treatment Bundle.
Omeza is a skin health and tissue regeneration company dedicated to equitable access to better wound care outcomes for all patients at all sites of care, reducing the rate of non-traumatic lower extremity amputations, hospitalizations due to skin infections and recurrence of chronic leg and foot wounds.