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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zenith™ + Standard care for DFU | Patients who received Zenith™ plus standard care for their DFU | ||
| Orion™ + Standard care for DFU | Patients who received Orion™ plus standard care for their DFU | ||
| SurGraft FT™ + Standard care for DFU | Patients who received SurGraft FT™ plus standard care for their DFU | ||
| Complete ACA™ + Standard care for DFU | Patients who received Complete ACA™ plus standard care for their DFU | ||
| Standard care alone for DFU | Patients who received standard care only for their DFU | ||
| Zenith™ + Standard care for VLU | Patients who received Zenith™ plus standard care for their VLU | ||
| Orion™ + Standard care for VLU | Patients who received Orion™ plus standard care for their VLU |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | From index visit to 12 weeks post-index |
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete wound closure | Time from the index visit to primary complete wound closure for wounds that heal during the study period | From index visit up to 24 months post-index |
| ≥50% wound area reduction at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with DFU, VLU, or PU
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Foot and Ankle | Colorado Springs | Colorado | 80903 | United States | ||
| Podiatric Surgical Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Kahoun, J., Gorenstein, S., & Gillette, B. (2025). Real-World Performance of Amniotic Membrane Allografts for Chronic Wounds: Multi-Site Results from a Retrospective EHR Study. https://doi.org/10.5281/zenodo.17504472 |
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| SurGraft FT™ + Standard care for VLU | Patients who received SurGraft FT™ plus standard care for their VLU |
| Complete ACA™ + Standard care for VLU | Patients who received Complete ACA™ plus standard care for their VLU |
| Standard care alone for VLU | Patients who received standard care only for their VLU |
| Zenith™ + Standard care for PU | Patients who received Zenith™ plus standard care for their PU |
| Orion™ + Standard care for PU | Patients who received Orion™ plus standard care for their PU |
| SurGraft FT™ + Standard care for PU | Patients who received SurGraft FT™ plus standard care for their PU |
| Complete ACA™ + Standard care for PU | Patients who received Complete ACA™ plus standard care for their PU |
| Standard care alone for PU | Patients who received standard care only for their PU |
Proportion of patients whose wounds close greater than 50% within 4 weeks from the index visit
| 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 | From index visit up to 24 months post-index |
| Clinton Township |
| Michigan |
| 48038 |
| United States |
| Advanced Wound Therapy | Tulsa | Oklahoma | 74137 | United States |
| Comprehensive Occupational Medicine | Nitro | West Virginia | 25143 | United States |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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