NCT04133493

Omega3 Wound Fish Skin Graft in the Treatment of DFUs

Active, enrolled NA Last updated 6 July 2022

What this trial tests

NA trial testing Kerecis Omega3 Wound in Diabetic Foot Ulcer in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

31 July 2019

Primary endpoint
30 December 2022

30 January 2023

Quick facts

Lead sponsor	Kerecis Ltd.
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	31 July 2019
Primary completion	30 December 2022
Estimated completion	30 January 2023
Sites	5 locations across United States

Drugs / interventions tested

• Kerecis Omega3 Wound
• Fibracol

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →

Sponsor

Kerecis Ltd.

Who can join

18 and older, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Updates on Recent Clinical Assessment of Commercial Chronic Wound Care Products.
   Sharma A, Sharma D, Zhao F. · · 2023 · cited 29× · PMID 37306401 · DOI 10.1002/adhm.202300556
2. Diabetic Wound Repair: From Mechanism to Therapeutic Opportunities.
   Wang R, Gu S, Kim YH, Lee A, et al · · 2025 · cited 5× · PMID 41030912 · DOI 10.1002/mco2.70406
3. Biomaterials Mimicking Mechanobiology: A Specific Design for a Specific Biological Application.
   Donati L, Valicenti ML, Giannoni S, Morena F, et al · · 2024 · cited 5× · PMID 39408716 · DOI 10.3390/ijms251910386