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Diabetic Foot Ulcer Solutions

Advanced biologic treatment with proven clinical outcomes for the most challenging chronic wounds

Understanding DFU

What Are Diabetic Foot Ulcers?

15-25%[DOI]
of Diabetic Patients
Develop DFU
Leading Cause of
Non-Traumatic Amputation
Multi-Factorial
Complex Pathophysiology
Requires Advanced Care

Epidemiology and Clinical Significance

Diabetic foot ulcers represent one of the most significant complications of diabetes mellitus, affecting an estimated 15-25% of diabetic patients at some point during their lifetime.[DOI] The economic burden is substantial, with DFU-related care costs exceeding billions annually in the United States alone. Despite advances in diabetes management, DFU prevalence continues to rise due to the growing global diabetes epidemic.

Perhaps most critically, DFUs remain the leading cause of non-traumatic lower limb amputation in developed nations.[DOI] Approximately 1-3% of diabetic patients with a foot ulcer will require amputation, while patients who have undergone amputation face further amputation risk exceeding 50% within 5 years.[DOI] This sobering reality underscores the critical importance of preventing, identifying, and aggressively treating diabetic foot ulcers.

Pathophysiologic Basis of DFU Development

The development of diabetic foot ulcers results from the complex interplay of multiple pathophysiologic factors inherent to diabetes. Rather than a single causative mechanism, DFUs typically develop at the intersection of several risk factors:

Primary Pathophysiologic Contributors:

  • Sensory Neuropathy: Loss of protective sensation prevents patients from detecting minor injuries, leading to continued trauma and ulcer development
  • Motor Neuropathy: Muscle atrophy and denervation cause abnormal foot biomechanics and excessive pressure distribution
  • Autonomic Neuropathy: Impaired sweating causes dry skin and increased fragility
  • Peripheral Vascular Disease: Microvascular and macrovascular disease impair oxygen and nutrient delivery
  • Impaired Immune Response: Hyperglycemia impairs neutrophil function, chemotaxis, and bacterial killing
  • Impaired Collagen Synthesis: Hyperglycemia-induced formation of advanced glycation end products (AGEs) impairs collagen cross-linking and strength
  • Biofilm Formation: Chronic wounds in diabetic patients develop complex polymicrobial biofilms resistant to systemic antibiotics

This multifactorial pathophysiology explains why DFUs are so notoriously difficult to heal and why comprehensive, multi-faceted treatment approaches are essential.

Treatment Challenges

Why DFUs Don't Heal

Traditional wound care approaches frequently fail in diabetic foot ulcers because they address wound management without adequately addressing the underlying pathophysiologic barriers to healing.

Cellular-Level Healing Impairment

Hyperglycemia impairs fibroblast function, reduces growth factor signaling, impairs collagen deposition, and promotes matrix degradation through excessive protease activity. Standard dressings alone cannot overcome these cellular dysfunction mechanisms.

Chronic Inflammatory State

Diabetic wounds exist in a pro-inflammatory state that impairs normal wound healing progression. Excessive inflammatory mediators promote matrix degradation rather than tissue construction.

Compromised Vascular Supply

Peripheral vascular disease limits oxygen and nutrient delivery, impairing fibroblast proliferation and collagen synthesis while reducing antibiotic efficacy. Wound healing remains limited regardless of local wound management alone.

Biofilm-Associated Resistance

Chronic diabetic wounds develop complex biofilms with polymicrobial communities that resist both systemic antibiotics and immune recognition, creating a hostile environment for healing.

Impaired Epithelialization

Keratinocyte migration and proliferation are significantly impaired in diabetic wounds, extending the epithelialization phase and extending overall healing time.

Mechanical and Metabolic Dysfunction

Neuropathy-related pressure abnormalities and metabolic derangements continue to perpetuate tissue damage even with aggressive local wound care.

Treatment Comparison

Traditional Approaches vs Advanced Biologics

Aspect Traditional Wound Care Biologic Scaffold Therapy
Mechanism Passive moisture management and protection Active biologic support for tissue regeneration
Growth Factor Support Relies on endogenous production (impaired in DFU) Provides exogenous growth factors and cytokine signaling
Inflammatory Modulation No active anti-inflammatory effect Omega-3 content promotes resolution of inflammation
Tissue Integration Passive surface coverage Active integration with wound bed, gradual resorption
Closure Rates 22.2% (published baseline)[DOI] 41.6% with Kerecis (peer-reviewed RCT)[DOI]
Healing Timeline Extended, variable Accelerated with evidence-based support
Advanced Biologic Solution

Kerecis Fish Skin Grafts for Diabetic Foot Ulcers

Mechanism of Action in DFU

Kerecis fish skin grafts are derived from omega-3 rich Atlantic cod skin and function as a natural biologic scaffold designed to support tissue regeneration in the challenging DFU environment. Unlike passive dressings, Kerecis actively integrates with the wound bed and provides multiple physiologic benefits:

🧬 Natural Scaffold

Provides structural matrix for fibroblast migration, neovascularization, and organized tissue formation

🧂 Omega-3 Content

Promotes anti-inflammatory signaling and supports wound healing progression from inflammatory to proliferative phases

🔄 Bioactive Molecules

Contains growth factors and cytokines that support fibroblast proliferation and collagen synthesis

💊 Progressive Integration

Gradually resorbs and integrates with patient's tissue, replaced by native tissue regeneration

SurgiClose Silicone for DFU

SurgiClose Silicone is Kerecis' intact fish skin with an integrated porous silicone contact layer, specifically suited for diabetic foot ulcer management in the hospital setting. The product characteristics address the unique challenges of DFU treatment:

  • Silicone Contact Layer: Reduces pain at dressing changes while maintaining graft-to-wound-bed contact in moist environments
  • Handling Characteristics: Available in multiple sizes (3x3 to 10x18 cm) for diverse DFU presentations, with easy application and wound bed integration
  • Integration Timeline: Progressive incorporation supports healing without premature graft failure or chronic inflammation
  • Wound Environment Support: Maintains optimal wound moisture balance while the preserved fish skin microstructure promotes cell ingrowth and revascularization
Peer-Reviewed Evidence

Clinical Outcomes with Kerecis for DFU

Multiple peer-reviewed clinical studies demonstrate the superiority of Kerecis fish skin grafts for diabetic foot ulcer treatment. The following represents key evidence from rigorous clinical investigation:

The Odinn Trial — Landmark Randomized Controlled Trial

Citation: Linden BJ, et al. (2024). Fish skin grafts versus standard of care for healing of plantar diabetic foot ulcers. NEJM Evidence.[DOI]

Primary Finding: 44% complete wound closure at 16 weeks with Kerecis fish skin graft vs. 26.4% with standard of care (p<0.001)[DOI]

Clinical Significance: The largest double-blind RCT for fish skin in DFU (255 patients). At 24 weeks, the gap widened to 55.2% vs. 37.8%. Median time to healing was approximately 2 weeks faster. No serious adverse events attributable to fish skin application.

Study Design: Double-blind, prospective RCT. Patients with plantar DFUs (UT grade 2–3) randomized 1:1 to fish skin graft + standard care vs. standard care alone. 12-month follow-up for recurrence.

View All Clinical Evidence →

Evidence Summary

The cumulative evidence demonstrates that Kerecis fish skin grafts provide superior healing outcomes across diverse diabetic foot ulcer populations, including standard DFU, wounds requiring combination therapy, and the challenging ischemic DFU subgroup. These results are consistent across multiple centers and clinical settings, supporting the robustness of the biologic therapy approach.

Clinical Application

Application Protocols Overview

The following represents a general overview of application principles for biologic wound scaffolds. Clinical protocols should be developed with input from experienced wound care specialists and should adhere to current clinical guidelines and institutional standards.

Pre-Application Considerations

  • Comprehensive wound assessment and classification
  • Vascular evaluation (ankle-brachial index, advanced imaging as indicated)
  • Infection assessment and treatment optimization
  • Debriment of nonviable tissue
  • Glycemic control optimization
  • Pressure offloading strategy implementation

Application Techniques

  • Proper wound bed preparation
  • Product application per manufacturer specifications
  • Integration with appropriate secondary dressing
  • Documentation of product application and wound characteristics
  • Dressing change frequency per clinical assessment
  • Serial wound photography for objective assessment

Ongoing Management

  • Regular wound assessment and measurement
  • Monitoring for signs of healing progression
  • Infection surveillance and management
  • Continuation of pressure offloading
  • Patient education and compliance assessment
  • Adjustment of treatment plan based on response

Expected Timeline

  • Visible healing typically begins within 2-4 weeks
  • Progressive granulation and epithelialization expected
  • Complete closure timeframe varies (4-12+ weeks)
  • Some DFU requiring multiple applications
  • Post-closure management and prevention focus
Important Clinical Note:

This overview is for educational purposes and does not constitute specific clinical guidance. Clinicians should refer to detailed product instructions for use, institution-specific protocols, and current clinical guidelines for optimal application and management strategies. Biologic dressings are adjunctive to comprehensive wound care, not replacements for essential assessments and interventions.

Provider Questions

Frequently Asked Questions for Providers

Kerecis should be considered for chronic DFU failing to progress with standard care, particularly in wounds that have been present for more than 4 weeks without significant improvement. The biologic scaffold is particularly indicated in DFU with adequate vascular supply and without active infection, though Lee et al. evidence suggests benefit even in ischemic wounds. Early consultation with wound care specialists for appropriate patient selection is recommended.
Treatment duration varies based on individual wound response, size, and complexity. Most clinical evidence suggests visible improvement within 2-4 weeks. Multiple applications may be necessary in large or complex wounds. Dressing change frequency should be determined based on clinical assessment and wound characteristics, typically ranging from 1-3 times weekly. Continued pressure offloading and glycemic control optimization remain essential throughout treatment.
Yes. The Lee study specifically examined ischemic DFU and demonstrated 82% healing rates with Kerecis compared to 45% control[DOI], suggesting significant benefit even in vascular-compromised situations. However, vascular assessment remains essential, and intervention (angioplasty, bypass) should be considered in appropriate candidates. Biologic support with Kerecis may enhance outcomes when combined with vascular optimization.
The Tan & Chng study demonstrated that combining Kerecis with NPWT achieves 100% closure rates in their case series[DOI]. NPWT provides mechanical support for wound closure and may optimize conditions for biologic graft integration. Combined approaches may be particularly beneficial in large, complex, or heavily contaminated wounds. Combination therapy decisions should be individualized based on clinical presentation.
Success assessment should include: objective wound measurements (length x width x depth), photographic documentation for visual comparison, assessment of granulation tissue quality and quantity, progress toward epithelialization, reduction in exudate and inflammation, and overall wound bed appearance. Serial measurements allow quantification of healing rate. Clinical assessment should also include patient pain levels, infection status, and overall functional improvement.
Kerecis should not be applied to actively infected wounds - infection must be addressed first. Wounds with inadequate blood supply (severe ischemia not amenable to intervention) have reduced healing potential despite biologic support. Patients with fish allergy require careful assessment before application. Comprehensive wound care foundations (offloading, glycemic control, vascular optimization) remain essential and cannot be replaced by biologic therapy alone.

Medical Disclaimer

This website and its content are intended for healthcare providers only. The information presented is educational in nature and does not constitute medical advice, clinical guidance, or treatment recommendations for specific patients.

For Patient Inquiries: If you are a patient seeking wound care solutions, please consult your healthcare provider for personalized medical evaluation and treatment recommendations appropriate for your specific condition.

Clinical Decision-Making: Optimal wound care requires comprehensive patient assessment, vascular evaluation, infection control, and management of underlying comorbidities. Biologic wound dressings are adjunctive to comprehensive wound care, not replacements for essential clinical assessments and interventions. All clinical decisions should be made in collaboration with qualified wound care specialists and in accordance with current clinical guidelines.

Evidence Interpretation: While the clinical studies cited demonstrate significant outcomes with Kerecis therapy, individual patient results may vary based on comorbidities, compliance, wound characteristics, and overall clinical management. Referral to published clinical guidelines and consultation with experienced wound care specialists is recommended for optimal patient management.

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Patient Notice: This website is intended for healthcare providers. The information here is educational and does not constitute medical advice. If you are a patient seeking wound healing solutions, please consult your healthcare provider for personalized medical advice and treatment recommendations.