Cleveland

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.

Researchers are evaluating the effectiveness of Hyalomatrix, a hyaluronic acid-based wound dressing, combined with standard of care SOC compared to SOC alone in treating venous leg ulcers. This open-label, randomized controlled trial includes adults diagnosed with venous leg ulcers or venous insufficiency with lower extremity wounds, aiming to assess wound healing over a 12-week period and support insurance reimbursement decisions. Participants will be randomly assigned to either receive SOC alone, which includes wound cleansing, sharps debridement, moisture-balancing dressings, and compression therapy, or SOC plus weekly Hyalomatrix applications. Subjects in the SOC group who do not achieve complete wound closure by about 84 days post-randomization and meet eligibility criteria may cross over to receive Hyalomatrix treatment for up to 12 weeks while continuing follow-up visits. During the study, participants will attend treatment visits where wound healing progress, pain levels, and wound area reduction are monitored regularly. Researchers will measure complete wound closure within 1 to 12 weeks as the primary outcome, along with weekly percentage area reduction and pain assessments for up to 14 weeks. The study emphasizes ongoing safety and efficacy monitoring throughout the treatment and follow-up periods.