This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
At least 18 years of age or older.
Diagnosis of type 1 or 2 Diabetes mellitus.
At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm² and a maximum surface area of 5.0 cm² measured post debridement.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
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.
Parallel
Standard of Care
Other interventionBeginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
EPIEFFECT
Other interventionParticipants will receive weekly applications of EPIEFFECT and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
EPIXPRESS
Other interventionParticipants will receive weekly applications of EPIXPRESS and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
Percentage of target ulcers achieving wound closure
The percentage of target ulcers achieving complete wound closure in 12 weeks.
Percent of wound closure area
Percentage wound area reduction from treatment visit (TV)-1 to TV-13 measured weekly with digital photographic planimetry and physical examination
Adverse Events
Number of adverse events will be evaluated weekly
Change in Pain in Target Ulcer
Change in pain in the target ulcer assessed using the Pain, Enjoyment of Life and General Activity (PEG) scale
Change in Quality of Life
Change in quality-of-life using the Wound Quality of Life (wQOL) questionnaire
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MiMedx Group, Inc.
Lead sponsor
SerenaGroup, Inc.
Collaborator
