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Largest RCT on DFUs with Exposed Bone or Tendon Brings New Hope for Patients

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Groundbreaking study fills critical gap in evidence-based treatment options for DFUs with exposed structure.

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 infection2
  • Up to 80% increased risk of amputation3
  • Increased healthcare costs per patient4
  • 5-year mortality rates of up to 45%5

These complex ulcers have long been a challenge for clinicians, with limited evidence-based treatment options available. Despite the devastating impact these deep ulcers often have on patients and their families, there has been a lack of large-scale, randomized controlled trials to investigate care options.

 

 

Wound Closed at 16 Weeks

 

Significant Results: (95% CI: 1.48 – 4.56)

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Odinn – Multicenter RCT on DFUs with exposed bone and tendon

The new study, titled Intact Fish Skin Graft to Treat Deep Diabetic Foot Ulcers: The Odinn Trial, changes that. It found that at 16 weeks, 44.0% of wounds treated with fish skin grafts (IFSG) had healed, compared to only 26.4% with standard of care (SOC) (p<0.001).

The trial involved 255 patients at 15 care centers across four countries.

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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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
1

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.

2

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.

3

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.

Kerecis is pioneering the use of fish skin and fatty acids in the globally expanding field of cellular therapy.
Kerecis is part of Coloplast, the leading global supplier of intimate healthcare products.
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