Clinical Research Studies

This post-marketing study is being performed to assess the effectiveness of Altrazeal® Transforming Powder Dressing (“Altrazeal®” or “TPD”) manufactured by ULURU Inc. in patients with pressure injuries (sometimes also referred to as pressure sores or decubitus ulcers) compared to the current Standard of Care (SOC) therapies. TPD is manufactured, marketed, and used in the United States of America (US). ULURU Inc. is registered with the US Food and Drug Administration (FDA) and Altrazeal® is listed as a Class I 510(k) exempt medical device: “dressing, wound, hydrogel without drug and/or biologic.” (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=410757&lpcd=NAE) Under the supervision of a health care professional, TPD may be used in surgical, acute or chronic wounds including pressure injuries. Objectives: Primary: To compare the efficacy of TPD in reducing primary dressing changes in the treatment of non-infected Stage 2, 3 and 4 pressure injuries (PrIs). Secondary: Evaluate: 1) wound healing trajectories 2) safety in the form of adverse events 3) subject pain for sensate patients Exploratory: Evaluate: 1) resource utilization of TPD relative to SOC 2) cost-effectiveness of TPD versus SOC 3) budget impact analysis of adopting TPD 4) wound quality of life 5) research subject satisfaction 6) other ad-hoc analyses as warranted