This retrospective multi-site observational cohort study uses electronic health records (EHR) from U.S. wound care centers to evaluate the effectiveness of four amniotic membrane allografts (Acesso DL, Acesso TL, Neostim DL, Neostim TL) when added to standard wound care for diabetic foot ulcers (DFU), venous leg ulcers (VLU), and pressure ulcers (PU). The primary endpoint is complete wound closure by 12 weeks. Secondary outcomes include time-to-closure, ≥50% wound-area reduction at 4 weeks, wound-related complications (infection, hospitalization, emergency department visits, and major/minor amputation).
Study Type
OBSERVATIONAL
Enrollment
2,000
Optalis
Novi, Michigan, United States
ProCure Health
Murfreesboro, Tennessee, United States
Complete wound closure at 12 Weeks
Proportion of index wounds with 100% epithelialization, no drainage or dressings; confirmation on ≥1 follow-up within 60 days
Time frame: From index visit to 12 weeks post-index
Time to complete wound closure
Time from the index visit to primary complete wound closure for wounds that heal during the study period
Time frame: From index visit up to 24 months post-index
≥50% wound area reduction at 4 weeks
Proportion of patients whose wounds close greater than 50% within 4 weeks from the index visit
Time frame: From index visit to 4 weeks post-index
Wound-related complications
Wound-related complications including infection requiring treatment, hospitalization, ED visits, and major or minor amputation
Time frame: From index visit up to 24 months post-index
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