About this trial
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.
Eligibility criteria
Qualifiers
18 years of age or older.
Hemoglobin A1c (HbA1c) level is <12% (108 mmol/mol).
Target ulcer with a surface area of between 1.0 cm 2 and 25.0 cm 2 measured post debridement at randomization.
Target ulcer must have been present for a minimum of 4 weeks with standard of care prior to the initial screening visit.
Disqualifiers
The participant must agree to attend the weekly study visits required by the protocol.
The participant must be willing and able to participate in the informed consent process
Known life expectancy of <6 months.
Target ulcer is infected or there is cellulitis in the surrounding skin.
Trial design
Treatments tested in this trial
- Amnion-Intermediate-Chorion
- Standard of Care (SOC)