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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 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.
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
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 253-participant average among 67 other Diabetic Foot Ulcer trials with a reported enrollment target (60% lower). The listed sponsor is Kerecis, which has 7 total studies on file at ClinicalTrials.gov.
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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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
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-
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-
Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
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-
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Read our methodology - how this data is sourced, computed, and verified.
Related
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