The largest randomized controlled trial in diabetic foot ulcers with exposed bone or tendon demonstrates significantly improved healing outcomes with fish skin grafts vs. standard of care (SOC).

Landmark Results from the Odinn RCT

66% more wounds healed at 16 weeks vs SOC
1.6x greater likelihood of healing
Faster time to closure (~2 weeks faster)

The largest RCT to date evaluating DFUs with exposed structure found that 66% more relative wounds healed at week 16 with Kerecis vs SOC — helping clinicians treat their most complex patients.

Why Deep DFUs with Exposed Structures Matter

DFUs classified as University of Texas (UT) grades 2 and 3 are some of the most challenging wounds to treat, and are associated with higher rates of infection, delayed healing, and increased risk of amputation.[1]

The increased risk associated with grade 2 and 3 diabetic foot ulcers stems from their depth and complexity.

Increased Depth and Complexity creates:

Penetration down through the dermis and subcutaneous tissue
Depth creates environment for bacterial growth
Exposed structures avascular and with limited capability for fighting infection
Granulation tissue needs to migrate over exposed structures

For patients with University of Texas (UT) grade 2 and 3 ulcers – the severe cases where bone or tendon is exposed – the stakes of having an open wound are high:

Higher risk of infection[2]
Up to 80% increased risk of amputation[3]
Increased healthcare costs per patient[4]
5-year mortality rates of up to 45%[5]

Kerecis understands that managing deep, complex DFUs can be difficult, especially when evidence-based options are limited. These wounds carry a significant burden for patients and their families, yet historically there has been little large-scale, randomized clinical data to help guide treatment decisions.

To help address this gap, the Odinn RCT was designed to evaluate healing outcomes in DFUs with exposed structures and provide clinicians with meaningful, comparative evidence comparing Kerecis to SOC.

Study Overview

Design: Multicenter RCT
Population: 255 patients with complex DFUs
Sites: 15 centers across 4 countries
Comparison:
- SOC
- vs. intact fish-skin graft (IFSG)

Primary Endpoint: Complete wound healing at 16 weeks

Key Findings

44.0% healed with IFSG vs 26.4% with SOC (p<0.001)
1.6× greater likelihood of healing at any time point
~2 weeks faster time to healing

Kerecis demonstrated superior outcomes for patients with deep DFUs compared to SoC

Specifically, Kerecis was 104% more likely to heal UT Grade 2 ulcers and 70% more likely to heal UT Grade 3 ulcers than SOC

The Odinn trial represents true level 1 evidence that advanced therapeutics such as intact fish skin grafts make a difference in the real world of deep and complex diabetic foot wounds

Dr. John Lantis

, MD

Site-Chief of Surgery at the Mount Sinai West Hospital, and study co-author.

Explore the Full Evidence

Frequently Asked Questions

The Odinn study is a landmark study representing the first large-scale RCT focused exclusively on UT grade 2 and 3 DFUs, involving 255 patients across 15 centers. The scale and focus of this trial provide unprecedented insights into the management of these complex wounds, offering clinicians and patients a new level of evidence in an area where it has been lacking. By specifically targeting these severe ulcers, the study addresses a critical unmet need in diabetic foot care.

The primary funding sources were the European Commission Fast Track to Innovation Horizon 2020 (80%) and Kerecis Ltd. (13%).

The study focused on complex ulcers with a higher associated healthcare cost. The Odinn study was designed to show efficacy for Intact fish skin grafts in complex DFUs with exposed bone and tendon (UT 2 and 3). The study was designed to fulfill all the clinical trial criteria of the AHRQ evidence criteria for Skin substitutes in the USA and criteria of European insurance programs to offer reimbursement coverage.

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Confidently Manage DFUs with MariGen

As you evaluate advanced options for challenging DFUs, MariGen offers a biologically rich, intact fish-skin graft designed to support healing in deep, complex wounds.
The MariGen product line includes multiple variations and sizes to meet diverse DFU needs and is indicated for full-thickness wounds extending through the dermis to deeper tissues— including subcutaneous fat, muscle, bone, and tendon.

This allows care providers to confidently manage DFUs with exposed structures using a solution backed by growing clinical evidence.

Need more information?

From the town of Isafjordur in northwest Iceland, Kerecis develops, manufactures, and sells patented fish skin soft tissue regeneration products that have regulatory approval in the United States, Europe and several other jurisdictions.

References

Prevalence of diabetes, diabetic foot ulcer, and lower extremity amputation among Medicare beneficiaries, 2006-2008.. Content last reviewed December 2019. Effective Health Care Program, Agency for Healthcare Research and Quality, Rockville, MD.

Armstrong, D. G., Boulton, A. J., & Bus, S. A. (2017). Diabetic foot ulcers and their recurrence. New England Journal of Medicine, 376(24), 2367-2375.

Lavery, L. A., Armstrong, D. G., & Harkless, L. B. (1996). Classification of diabetic foot wounds. The Journal of Foot and Ankle Surgery, 35(6), 528-531.

⁴

Rice, J. B., Desai, U., Cummings, A. K., Birnbaum, H. G., Skornicki, M., & Parsons, N. B. (2014). Burden of diabetic foot ulcers for Medicare and private insurers. Diabetes Care, 37(3), 651-658.

⁵

Moulik, P. K., Mtonga, R., & Gill, G. V. (2003). Amputation and mortality in new-onset diabetic foot ulcers stratified by etiology. Diabetes Care, 26(2), 491-494.

Breakthrough Evidence in Complex DFUs with Exposed Structures