A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
Cellution Biologics
Summary
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 diabetic foot.
Description
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 chronic wounds is extremely challenging as ulcers such as DFUs may not respond to standard of care (SOC) treatment and frequently become infected. Advanced wound products like Dehydrated Human Placental Tissue (dHPTs) have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients' own cells to rebui…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects will be eligible to participate in the study if the following conditions exist: Inclusion Criteria: 1. 18 years of age or older. 2. Diagnosis of type 1 or 2 Diabetes mellitus. 3. Hemoglobin A1c (HbA1c) level is \< 12% (108 mmol/mol). 4. Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement. 5. Target ulcer present for minimum of 4 weeks prior to screening visit. 6. Target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 7. Target ulcer must be Wagner 1 or 2 grade, extending at leas…
Interventions
- OtherAmnion-Intermediate-Chorion
Dehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
- ProcedureStandard of Care (SOC)
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.
Locations (8)
- 005Santa Rosa, California
- 001Jacksonville, Florida
- 003Chicago, Illinois
- 007Mooresville, North Carolina
- 002Rocky Mount, North Carolina
- 008Allentown, Pennsylvania