Omega3 Wound Fish Skin Graft in the Treatment of DFUs (NCT04133493)
A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Omega3 Wound Fish Skin Graft in the Treatment of Diabetic Foot Ulcers
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Eric J. Lullove DPM, PA — Coconut Creek, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Eric J. Lullove DPM, PA — Coconut Creek, Florida
- Village Podiatry Centers - Smyrna (Allen Raphael, DPM) — Smyrna, Georgia
- Christopher Winters, DPM — Carmel, Indiana
- Brock Liden, DPM — Circleville, Ohio
- Bert J. Altmanshofer, DPM — Duncansville, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetic Foot Ulcer
- At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers — Baltimore, Maryland
- A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot — San Francisco, California
- Efficacy of ProgenaMatrix™ in the Management of DFUs — Puyallup, Washington
- Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management — Palm Springs, California
- NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers — Phoenix, Arizona
Explore by condition: All Diabetic Foot Ulcer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.