The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care 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.
If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the BIOCAMP study.
The potential subject must consent to using the prescribed offloading method for the duration of the study.
The potential subject is known to have a life expectancy of < 6 months.
The potential subject's target ulcer is not secondary to diabetes.
The target ulcer is infected or there is cellulitis in the surrounding skin.
The target ulcer exposes tendon or bone.
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Treatment groupsSee each treatment group below.
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United StatesBioLab Holdings
Lead sponsor
Serena Group
Collaborator