Integra LifeSciences Corporation
The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers.
Hard to heal Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of hard to heal chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers (VLUs) may not respond to standard of care (SC) treatment and frequently become infected. Advanced wound products like CAMPs have become an important strategy in the treatment of hard-to-heal chronic wounds by trapping and binding the pat…
Inclusion Criteria #1: Diabetic Foot Ulcers 1. Subjects must be at least 21 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. At Screening Visit 1 and at Randomization, target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement. 4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit. 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 6. The target u…
Application of Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Application of Urinary Bladder Matrix (UBM) sheet device, a porcine-derived extracellular matrix scaffold, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Application of AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Application of AmnioExcel Plus, a tri-layer (amnion-chorion-amnion) dehydrated human placental membrane allograft, and participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.