Omega3 Wound Fish Skin Graft in the Treatment of DFUs
Public ClinicalTrials.gov record NCT04133493. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Omega3 Wound Fish Skin Graft in the Treatment of Diabetic Foot Ulcers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04133493
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 30, 2019
- Primary completion
- Dec 29, 2022
- Completion
- Jan 29, 2023
- Last update posted
- Jul 5, 2022
2019 – 2023
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Eric J. Lullove DPM, PA | Coconut Creek | Florida | 33073 | — |
| Village Podiatry Centers - Smyrna (Allen Raphael, DPM) | Smyrna | Georgia | 30082 | — |
| Christopher Winters, DPM | Carmel | Indiana | 46032 | — |
| Brock Liden, DPM | Circleville | Ohio | 43113 | — |
| Bert J. Altmanshofer, DPM | Duncansville | Pennsylvania | 16635 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04133493, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 5, 2022 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04133493 live on ClinicalTrials.gov.