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NCT04133493 · ClinicalTrials.gov registry record · NA
Omega3 Wound Fish Skin Graft in the Treatment of DFUs
A NA study of Diabetic Foot Ulcer, sponsored by Kerecis.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 5
- Study locations
NCT04133493: Active NA study of Diabetic Foot Ulcer, sponsored by Kerecis.
NCT04133493 is a NA study of Diabetic Foot Ulcer that is active but no longer recruiting, run by Kerecis. The registered enrollment target is 100 participants, below the 253-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (60% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04133493, a NA study of Diabetic Foot Ulcer, is active but no longer recruiting, sponsored by Kerecis.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 5
- Study locations
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
Primary Outcome
A comparison of the proportion of index ulcers healed at 12 weeks. This is a "Yes/No" assessment The wounds can either be "healed" or "not healed".
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 |
What the registry record for NCT04133493 still lists
NCT04133493 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 253-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (60% lower).
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.
NCT04133493 lists 5 locations in 5 states (Florida, Georgia, Indiana).
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.
What interventions are being tested in trial NCT04133493?
The interventions under investigation include: Kerecis Omega3 Wound (DEVICE), Fibracol (DEVICE).
Who is sponsoring clinical trial NCT04133493?
This trial is sponsored by Kerecis, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04133493's enrollment target sits among peer trials
100 37th of 67 higher than 28 of 67 other Diabetic Foot Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
RECRUITING · NA
-
Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC
RECRUITING · NA
-
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
RECRUITING · NA
-
Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
RECRUITING · NA
-
Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
RECRUITING · NA
-
Exercise Enhances Wound Healing in Patients With Diabetic Foot Ulcers
RECRUITING · NA
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