The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
The potential subject must be at least 18 years of age or older.
The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus.
At enrollment, the potential subject must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20 cm2 measured post debridement with the eKare inSight® imaging device.
The potential subject must have a target ulcer that has been present for a minimum of 4 weeks of standard of care, prior to the initial screening visit.
The potential subject must consent to using the prescribed offloading method for the duration of the study.
The potential subject must agree to attend the weekly study visits required by the protocol.
The potential subject must be willing and able to participate in the informed consent process.
The potential subject is known to have a life expectancy of < 6 months.
10
Treatment groupsSee each treatment group below.
Map coordinates are unavailable for these locations. Locations are shown below instead.
United StatesBioLab Holdings
Lead sponsor
SerenaGroup, Inc.
Collaborator