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).
The CAMPAIGN trial is evaluating PURION Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM) and Standard of Care versus Standard of Care alone in the treatment of Nonhealing Diabetic Foot Ulcers. The study will evaluate two products, EPIEFFECT® and EPIXPRESS™, which are both ppLHACMs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Beginning 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.
Participants will receive weekly applications of EPIEFFECT and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
Participants will receive weekly applications of EPIXPRESS and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first
SerenaGroup - Monroeville
Monroeville, Pennsylvania, United States
RECRUITINGPercentage of target ulcers achieving wound closure
The percentage of target ulcers achieving complete wound closure in 12 weeks.
Time frame: 1 - 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
Time frame: 1 - 12 weeks
Adverse Events
Number of adverse events will be evaluated weekly
Time frame: 1 - 12 weeks
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
Time frame: 1 - 12 weeks
Change in Quality of Life
Change in quality-of-life using the Wound Quality of Life (wQOL) questionnaire
Time frame: 1 - 12 weeks
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