Comparing Standard Care With and Without Omeza Complete Matrix for Healing Diabetic Foot Ulcers Randomized Trial with Crossover for Non-Healing Ulcers

What this Trial Is About

Researchers are evaluating two treatment approaches for diabetic foot ulcers DFUs to determine if adding Omeza Complete Matrix OCM to the standard of care SOC improves the chances of complete wound healing. This open-label study involves adult participants diagnosed with Type I or II diabetes who have DFUs that have not healed significantly with SOC alone. The trial includes a randomized design with a crossover option for participants whose wounds do not fully close after initial treatment. Participants will be randomly assigned to receive either SOC alone or SOC combined with OCM. SOC includes surgical sharp debridement, offloading using a total contact cast TCC or fixed ankle-walker, and proper moisture balance. Those in the SOC group who do not achieve complete wound closure by about 84 days post-randomization may cross over to receive OCM applications weekly for up to 12 visits. The study is conducted across multiple medical centers and gathers data on treatment efficacy while aiding insurance reimbursement decisions. During the study, participants will attend regular visits to receive their assigned treatments and undergo wound assessments, including measuring wound area changes and pain levels. Researchers will monitor complete wound closure within 1 to 12 weeks as the primary outcome. Secondary outcomes include changes in wound size and pain assessment. The total study duration extends up to March 2027, with ongoing follow-up after treatment. Participants must meet specific health and wound criteria and follow protocol requirements throughout the trial.

Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers