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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acesso DL + Standard care for DFU | Patients who received Acesso DL plus standard care for their DFU | ||
| Acesso TL + Standard care for DFU | Patients who received Acesso TL plus standard care for their DFU | ||
| Neostim DL + Standard care for DFU | Patients who received Neostim DL plus standard care for their DFU | ||
| Neostim TL + Standard care for DFU | Patients who received Neostim TL plus standard care for their DFU | ||
| Standard care alone for DFU | Patients who received standard care only for their DFU | ||
| Acesso DL + Standard care for VLU | Patients who received Acesso DL plus standard care for their VLU | ||
| Acesso TL + Standard care for VLU | Patients who received Acesso TL 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 |
|---|---|---|---|---|---|---|
| Optalis | Novi | Michigan | 48375 | United States | ||
| ProCure Health |
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| Neostim DL + Standard care for VLU | Patients who received Neostim DL plus standard care for their VLU |
| Neostim TL + Standard care for VLU | Patients who received Neostim TL plus standard care for their VLU |
| Standard care alone for VLU | Patients who received standard care only for their VLU |
| Acesso DL + Standard care for PU | Patients who received Acesso DL plus standard care for their PU |
| Acesso TL + Standard care for PU | Patients who received Acesso TL plus standard care for their PU |
| Neostim DL + Standard care for PU | Patients who received Neostim DL plus standard care for their PU |
| Neostim TL + Standard care for PU | Patients who received Neostim TL 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 |
| Murfreesboro |
| Tennessee |
| 37129 |
| 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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