NCT04257370 (Odinn) is a NA clinical trial of Kerecis™ Omega3 Wound in Diabetic Foot Ulcer, sponsored by Kerecis Ltd..

Who is sponsoring NCT04257370?

NCT04257370 is sponsored by Kerecis Ltd..

What drugs are being tested in NCT04257370?

Interventions in NCT04257370: Kerecis™ Omega3 Wound, Standard of care.

What condition does NCT04257370 study?

NCT04257370 studies Diabetic Foot Ulcer, Dehiscence of Amputation Stump, Amputation.

Is NCT04257370 still recruiting?

NCT04257370 is currently completed. Last updated 6 February 2023.

Last reviewed 2023-02-06 · How we verify

NCT04257370: Odinn

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations

Completed NA Last updated 6 February 2023

What this trial tests

NA trial testing Kerecis™ Omega3 Wound in Diabetic Foot Ulcer in 260 participants. Completed in 25 November 2022.

Timeline

9 July 2020

Primary endpoint
30 September 2022

25 November 2022

Quick facts

Lead sponsor	Kerecis Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	260
Start date	9 July 2020
Primary completion	30 September 2022
Estimated completion	25 November 2022
Sites	1 location across France

Drugs / interventions tested

Kerecis™ Omega3 Wound
Standard of care

Conditions studied

Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
Dehiscence of Amputation Stump — all drugs for Dehiscence of Amputation Stump →
Amputation — all drugs for Amputation →

Sponsor

Kerecis Ltd.

Who can join

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

Sponsor's own description

This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint. Patients will be randomised to received intact fish skin (Kerecis™ Omega3 Wound) plus standard of care or standard of care alone, and wound healing compared over 16 weeks.

Publications & conference data

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

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
Intact Fish Skin Graft to Treat Deep Diabetic Foot Ulcers.
Dardari D, Piaggesi A, Potier L, Sultan A, et al · · 2024 · cited 9× · PMID 39365895 · DOI 10.1056/evidoa2400171
Intent to Treat Analysis of the Primary and Secondary Outcomes for the ODINN Intact Fish Skin Graft for Deep Diabetic Foot Wounds Trial.
Dardari D, Piaggesi A, Potier L, Sultan A, et al · · 2026 · PMID 41771582 · DOI 10.1111/iwj.70847

Verify or expand the search:

Other recruiting trials for Diabetic Foot Ulcer

Currently open trials in the same condition.

NCT07161830 — Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers · NA · recruiting
NCT07396376 — Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers · Phase 1, PHASE2 · recruiting
NCT07291817 — Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study · NA · recruiting
NCT07209358 — EDX110 Randomized Control Trial for Treatment of DFUs · NA · recruiting
NCT06938685 — Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers · NA · recruiting

Other Kerecis Ltd. trials

Trials by the same sponsor.

NCT06073301 — AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF · Phase 4 · active not recruiting
NCT05898698 — Prospective Case Registry for Wounds · active not recruiting
NCT05898711 — Kerecis Case Registry for SurgiBind : Soft Tissue Reinforcement · active not recruiting
NCT04357990 — Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19 · NA · completed
NCT04133493 — Omega3 Wound Fish Skin Graft in the Treatment of DFUs · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04257370 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kerecis Ltd.
Last refreshed: 6 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04257370.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing