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Omega3 Wound Fish Skin Graft in the Treatment of DFUs
NCT04133493 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound. In this trial, two groups of UT grade IA/1C diabetic foot ulcers (DFUs), full skin thickness or extending through the subcutaneous or fat layers but not into tendon, muscle, or bone will receive standard of care (SOC) treatment for their condition. Patients will be randomized to SOC treatment and a 510k FDA-approved collagen alginate dressing (Fibracol Plus) or SOC and KerecisTM Omega3 Wound. The primary endpoint is the percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks in which two groups that will be compared are SOC with Fibracol Plus or SOC with KerecisTM Omega3 Wound
Conditions Studied
Interventions
- DEVICE Kerecis Omega3 Wound
- DEVICE Fibracol
Study Locations (5)
Florida
- Eric J. Lullove DPM, PA — Coconut Creek
Georgia
- Village Podiatry Centers - Smyrna (Allen Raphael, DPM) — Smyrna
Indiana
- Christopher Winters, DPM — Carmel
Ohio
- Brock Liden, DPM — Circleville
Pennsylvania
- Bert J. Altmanshofer, DPM — Duncansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-07-31 |
| Est. Completion | 2023-01-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04133493
The ClinicalTrials.gov registry entry for NCT04133493 describes a study currently listed as active not recruiting. 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 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kerecis, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetic Foot Ulcer appearing as the primary indexed condition, and to 2 interventions — of which Kerecis Omega3 Wound 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: NCT04133493 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Florida, Georgia, Indiana. 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 NCT04133493 about?
NCT04133493 is a clinical study titled "Omega3 Wound Fish Skin Graft in the Treatment of DFUs". The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound. In this trial, two groups of UT grade IA/1C diabetic foot ulcers (DFUs), full s...
What is the current status of trial NCT04133493?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2019-07-31. Estimated completion is 2023-01-30.
What conditions does trial NCT04133493 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04133493?
The interventions under investigation include: Kerecis Omega3 Wound (DEVICE), Fibracol (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04133493?
This trial is sponsored by Kerecis, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04133493 being conducted?
This trial has 5 study locations across Florida, Georgia, Indiana, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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