Cellution Biologics
The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of venous leg ulcers.
In 2020, more than 4.5 billion people around the world were estimated to have chronic venous disease stages C1-C6, and approximately 3 in every 1000 people globally develop a VLU annually. While the pathophysiology of VLUs is complex, risk factors are thought to include noncompliance with compression therapy, incorrect ulcer diagnosis, obesity, and a history of deep vein thrombosis. It is estimated that 7% of VLUs do not heal within a 12-month period. As with DFUs, treatment of VLUs focuses on prevention. Low-income individuals, especially those from minority communities, often face difficulti…
Inclusion Criteria: Participants are required to meet all the following criteria for enrollment into the study: 1. 18 years of age or older. 2. Hemoglobin A1c (HbA1c) level is \<12% (108 mmol/mol). 3. Target ulcer with a surface area of between 1.0 cm 2 and 25.0 cm 2 measured post debridement at randomization. 4. Target ulcer must have been present for a minimum of 4 weeks with standard of care prior to the initial screening visit. 5. Affected limb must have adequate perfusion confirmed by vascular assessment performed within 90 days of screening visit. Any of the following methods are accep…
Dehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
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