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Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers.
NCT07219004 · View on ClinicalTrials.gov ↗
Study Summary
This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.
Conditions Studied
Interventions
- OTHER amniotic membrane
Study Locations (5)
Texas
- The Serena Group Austin Research Center — Austin
- El Campo Memorial Advanced Wound Care Clinic — El Campo
Florida
- Three Rivers Wound and Hyperbaric Center — North Port
New York
- Serena Group Reseach Center — Buffalo
Pennsylvania
- Serena Group — Monroeville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-03-03 |
| Est. Completion | 2023-09-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07219004
The ClinicalTrials.gov registry entry for NCT07219004 describes a study currently listed as completed. It is categorized as NA, 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 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tides Medical, 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 2 conditions, with Diabetic Foot Ulcer (DFU) appearing as the primary indexed condition, and to 1 intervention — of which amniotic membrane 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: NCT07219004 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Texas, Florida, New York. 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 NCT07219004 about?
NCT07219004 is a clinical study titled "Artacent Amniotic Tissue for Treatment of Chronic Lower Extremity Diabetic Ulcers.". This is study is to determine if A tri-layered dehydrated human amnion/chorion/amnion composite graft would help non-healing lower extremity diabetic ulcers to heal over a 12 week time period.
What is the current status of trial NCT07219004?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2023-03-03. Estimated completion is 2023-09-27.
What conditions does trial NCT07219004 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer (DFU), Lower Extremity Chronic Ulcers in Diabetics. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07219004?
The interventions under investigation include: amniotic membrane (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07219004?
This trial is sponsored by Tides Medical, 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 NCT07219004 being conducted?
This trial has 5 study locations across Florida, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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