Positive Results from Diabetic Foot Ulcer Clinical Trial Show Dramatic Healing Rate within 12 Weeks or Less Using Novel Omeza® Platform and Offloading
SARASOTA, Fla., March 14, 2024 /PRNewswire/ -- Omeza®, a regenerative skincare company that develops marine-based therapies for the treatment of chronic wounds, today presented positive interim data from a diabetic foot ulcer (DFU) clinical trial showing that Omeza® OCM™ plus offloading of weight on the affected foot achieved a 91 percent area reduction (PAR) rate in DFUs within twelve weeks, and a 63 percent PAR within four weeks. PAR is considered a surrogate endpoint of complete wound healing, with a PAR of 50 percent at four weeks in diabetic wound patients considered a strong predictor of subsequent complete healing.1
The interim data are being presented at the Cellular, Acellular, and Matrix-Like Products Wound Care Summit (CAMPs) March 13-14 in Miami, and the completed data set demonstrating even stronger results is being submitted for publication in a peer-reviewed wound journal.
"Diabetic foot ulcers are one of the leading causes of mortality, morbidity, and lower extremity amputations in patients with diabetes, and the medical community continuously strives to identify novel therapies to prevent or reduce these complications and their significant burden to patients, families, and the healthcare system at large," said Dr. Richard Simman, Professor of Plastic Surgery at the University of Toledo College of Medicine, Jobst Vascular Institute at ProMedica Health System in Toledo, Ohio. Promedica conducted the DFU clinical trial.
"In evaluating Omeza®'s platform, the first twelve patients treated in the study demonstrated significant healing—and in some cases, complete closure—of their diabetic wounds in twelve weeks or less, which is a notable achievement, given the resistance to standard treatments that DFUs often display," said Simman, principal investigator at the Promedica clinical trial site.
In the study, patients with DFUs were treated with OCM™, a drug/device containing cold water fish peptides and other pharmaceutical-grade components that create an absorbable matrix which conforms to the wound bed and supports the synthesis of new tissue. Patients also received standard of care, which included offloading—no weight-bearing by the foot—to support healing.
By week four of treatment, the average PAR was 63 percent, with two patients achieving complete wound closure. By week twelve, the average PAR was 91 percent, with two additional patients achieving complete closure of their DFUs. Both of these cases were of ≥1 year duration prior to treatment with OCM™ and off-loading. No adverse events related to treatment were reported during the study.
"We continue to be encouraged by the high rates of wound closure experienced by patients in our three studies that are currently underway, and we look forward to obtaining further confirmation of OCM's™ ability to treat advanced wounds from day one, as well as to transition chronic wounds from a stalled state to a healing state more quickly and completely than other products on the market," said Desmond Bell, DPM, Chief Medical Officer at Omeza®.
"All of the components in our platform are natural, pharmaceutical-grade ingredients that are known to be safe and have been shown to harness an individual's innate immune processes to activate healing at the site of the wound," Bell said. "Our ongoing in vivo and in vitro studies will further elucidate the mechanisms of action that underlie the exciting results we're accumulating in clinical trials and the real-world setting."
Reference:
1 https://www.jvascsurg.org/article/S0741-5214(22)02154-1/fulltext
About OMEZA
Omeza is a commercial-stage regenerative skin and wound-care company that develops marine-based products comprising essential omega fatty acids and hydrolyzed fish collagen infused with cod liver oil. Founded in 2014, the company currently markets Omeza Complete Matrix (OCM™) designed to reduce inflammation, increase tissue proliferation, and support skin remodeling in adults with a range of chronic, non-healing wounds. Omeza is currently conducting three clinical trials in patients with diabetic ulcers, chronic venous leg ulcers, and multiple other etiologies to evaluate the effects of Omeza Combination Therapy versus standard of care on wound healing, pain reduction, quality of life, and additional secondary endpoints. The company is headquartered in Sarasota, Florida, and has research, manufacturing, and analytical facilities located throughout Florida.
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Bernadette Cupit
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SOURCE Omeza LLC
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