Omeza is sponsoring a randomized, multi-center, open-label study comparing the Omeza® Products Bundle versus standard of care treatments for 2 different types of chronic ulcers. After considering a lengthy list of potential investigators, they narrowed the list of principal investigators to Dr. Robert McLafferty at Oregon State University Health system, Dr. Andrew J. (“A.J.”) Applewhite at Baylor Southwest Health, and Dr. Jacob Reinkraut at St. Michael’s Medical Center, Newark, NJ.
Omeza Chief Medical Officer Desmond Bell, DPM, confirms that all three have dedicated their professional careers to lower extremity preservation and wound healing through clinical practice and academics and are exceptional leaders. All are multi-talented patient advocates who seek advancements for both patients and fellow providers by raising standards for development and implementation of technology and increasing the knowledge and science of wound healing among their colleagues.
“I have known and worked with Drs. McLafferty and Applewhite on multiple projects over the years,” states Dr. Bell, “including service as fellow faculty members for a variety of wound conferences and publications. Dr. Reinkraut is a fellow podiatrist who has established himself as a leader in our profession.”
The trials, governed by Institutional Review Boards (IRBs) will evaluate approximately 78 participants with Venous Leg Ulcers or Diabetic Foot Ulcers and will measure wound closure from baseline, wound closure rates, and number of weeks to full wound closure.
In screening participants, the MESI ABPI MD by Medi USA will be used to compute Ankle-Brachial Index (ABI) measurements to ensure the study doesn’t accidentally include patients with significant peripheral arterial disease which would preclude healing. To provide extremely accurate data on wound size, investigators will employ Swift Medical’s imaging technology. The Swift App is a smartphone-ready program that captures wound measurement, images and data without touching the wound.
Dr. Bell is the author of the protocol, including controls and inclusion/exclusion criteria and schedules. Recruiting for participants has begun.