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.
Parallel
Tri-Membrane Wrap™ DFU
Other interventionParticipants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Membrane Wrap™ DFU
Other interventionParticipants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Membrane Wrap-Lite™ DFU
Other interventionParticipants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Membrane Wrap-Hydro™ DFU
Other interventionParticipants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Tri-Membrane Wrap™ VLU
Other interventionParticipants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Membrane Wrap™ VLU
Other interventionParticipants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Membrane Wrap-Lite™ VLU
Other interventionParticipants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Membrane Wrap-Hydro™ VLU
Other interventionParticipants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
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Treatment groupsSee each treatment group below.
Percentage of Wound Closure
The percentage of target ulcers achieving complete wound closure in 12 weeks.
Time to Closure
Time to closure for the target ulcer.
Percentage Area Reduction
Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination.
Adverse Events
The number of product- or procedure- related adverse events.
Determine improvement in Quality of Life
To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) questionnaire. Forgotten wound scores situations on a scale of "never" to "mostly."
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United StatesClick on the lead sponsor to view all of their trials.
BioLab Holdings
Lead sponsor
Serena Group
Collaborator
