Diabetic Foot Ulcer (DFU), Pressure Ulcers, Bedsores, Decubitus Ulcer, Venous Leg Ulcers (VLUs)
Conditions
Keywords
real world evidence, wound healing
Brief summary
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone. The study will use complete electronic health records (EHR) from multiple wound care centers across the United States (2022-2025) to generate study data for product-treated and propensity score-matched standard care cohorts for each product-indication combination. The overall study comprises 12 parallel sub-studies (one for each product-wound type combination), each aiming to answer whether adding the product improves healing outcomes versus standard care alone in that indication. The primary endpoint is the proportion of wounds achieving complete closure within 12 weeks, with subgroup analyses by wound severity measures, age groups, and number of product applications. Secondary outcomes are time-to-healing, early wound improvement (≥50% reduction in wound area by 4 weeks), wound-related complications, and subgroup analyses.
Interventions
None listed
Sponsors
Legacy Medical Consultants
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults ≥18; DFU/VLU/PU; sufficient observable timeline
Exclusion criteria
* Use of other advanced wound products, atypical ulcer etiology (e.g., malignancy, vasculitis); insufficient follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete wound closure at 12 Weeks | From index visit to 12 weeks post-index | Proportion of index wounds with 100% epithelialization, no drainage or dressings; confirmation on ≥1 follow-up within 60 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete wound closure | From index visit up to 24 months post-index | Time from the index visit to primary complete wound closure for wounds that heal during the study period |
| ≥50% wound area reduction at 4 weeks | From index visit to 4 weeks post-index | Proportion of patients whose wounds close greater than 50% within 4 weeks from the index visit |
| Wound-related complications | From index visit up to 24 months post-index | Wound-related complications including infection requiring treatment, hospitalization, ED visits, and major or minor amputation |
Countries
United States
Outcome results
None listed