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Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
NCT07209475 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.
Conditions Studied
Interventions
- BIOLOGICAL Amnio-Maxx® Dual Layer Amnion Patch
- OTHER Standard of Care (Investigator Choice)
Study Locations (8)
Texas
- VAST Clinical Research Carrollton Foot Center — Carrollton
- Elite Foot & Ankle Associates — Spicewood
California
- Lion Heart Clinical Research — Burbank
Florida
- Royal Research South — Miami
Georgia
- Denali Health Atlanta, LLC — Stone Mountain
Nebraska
- SerenaGroup Research Center — Omaha
New York
- Suffolk Foot and Ankle — East Patchogue
Oklahoma
- Wound Care of Tulsa — Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2025-08-14 |
| Est. Completion | 2026-08-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07209475
The ClinicalTrials.gov registry entry for NCT07209475 describes a study currently listed as recruiting. It is categorized as Phase 4, 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 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Royal Biologics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Diabetic Foot Ulcer (DFU) appearing as the primary indexed condition, and to 2 interventions — of which Amnio-Maxx® Dual Layer Amnion Patch is the first listed. 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: NCT07209475 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Texas, California, Florida. 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 NCT07209475 about?
NCT07209475 is a clinical study titled "Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.". This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs). The study will evaluate Amnio-Maxx® Dual Layer Amnion Patch.
What is the current status of trial NCT07209475?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 248 participants. The study started on 2025-08-14. Estimated completion is 2026-08-14.
What conditions does trial NCT07209475 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer (DFU), Amnio-Maxx. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07209475?
The interventions under investigation include: Amnio-Maxx® Dual Layer Amnion Patch (BIOLOGICAL), Standard of Care (Investigator Choice) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07209475?
This trial is sponsored by Royal Biologics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07209475 being conducted?
This trial has 8 study locations across California, Florida, Georgia, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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