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 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

NCT Number	NCT04133493
Lead Sponsor	Kerecis Ltd.
Conditions	Diabetic Foot Ulcer
Enrollment	100 participants
Start Date	2019-07-31
Primary Completion	2022-12-30 (estimated)
Study Completion	2023-01-30 (estimated)
Updated on ClinicalTrials.gov	2022-07-06