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Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
NCT07223281 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Study Locations (4)
Colorado
- Colorado Foot and Ankle — Colorado Springs
Michigan
- Podiatric Surgical Specialists — Clinton Township
Oklahoma
- Advanced Wound Therapy — Tulsa
West Virginia
- Comprehensive Occupational Medicine — Nitro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,400 participants |
| Start Date | 2025-09-25 |
| Est. Completion | 2025-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07223281
The ClinicalTrials.gov registry entry for NCT07223281 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Legacy Medical Consultants, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Diabetic Foot Ulcer (DFU) appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07223281 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Colorado, Michigan, Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07223281 about?
NCT07223281 is a clinical study titled "Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU". 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...
What is the current status of trial NCT07223281?
This trial is currently active not recruiting. The enrollment target is 2,400 participants. The study started on 2025-09-25. Estimated completion is 2025-12.
What conditions does trial NCT07223281 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT07223281?
This trial is sponsored by Legacy Medical Consultants, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07223281 being conducted?
This trial has 4 study locations across Colorado, Michigan, Oklahoma, West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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