Human Amnion/Chorion Membrane in Diabetic Foot Ulcer Treatment

DIABETIC FOOT ULCERS

Transformative Solutions for Diabetic Foot Ulcers

Transform your diabetic foot ulcer care with advanced dehydrated human amnion/chorion membrane (dHACM) therapy – the clinically proven solution for accelerated healing and reduced complications.

Complete Healing in
12 Weeks

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Average Days to Healing

Fewer Major Amputations

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Success with Proper Debridement

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Significant cost savings

Medicare Approved

Diabetic Foot Wound Healing

Transforming DFU Care

Our advanced dHACM treatment protocol addresses the complex challenges of diabetic foot ulcers through a comprehensive approach that delivers consistently superior outcomes.

Rapid Healing Technology

Our innovative multi-component compression system shows a remarkable 35% wound closure rate after just six weeks, with 87% of patients showing significant improvement.

Simple Application System

Efficient, effective treatment delivery optimized for the high-throughput environments of outpatient wound care clinics, for optimal clinical results and maximum productivity.

Cost-Effective Care

Reduces overall treatment costs by up to 3x compared to traditional methods. Studies show the potential savings of substantial savings with our advanced therapy.

Evidence-Based Protocol

Developed from extensive clinical research and real-world data from 81 U.S. wound care centers, ensuring optimal outcomes across all patient populations.

Enhanced Patient Comfort

Designed for maximum patient comfort and adherence with flexible materials that conform perfectly to the leg with minimal slippage, even during regular activities.

Advanced Cellular Technology

Incorporates cellular and tissue-based products (CTPs) that work synergistically with compression therapy to accelerate healing in challenging chronic wounds.

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Complete Healing in 12 Weeks

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Average Days to Healing

Fewer Major Amputations

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Success with Proper Debridement

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Advanced Treatment

VenoHeal™ Advanced Treatment System

Our flagship product combines innovative compression technology with bioactive materials to create the optimal healing environment for venous leg ulcers.

Intelligent Pressure Distribution

Provides consistent 40mmHg compression with graduated pressure distribution to maximize venous return while remaining comfortable for patients.

Visual Application Indicators

Unique pattern guides proper application technique, ensuring consistent compression with each application regardless of caregiver experience level.

Moisture Management Technology

Advanced materials actively manage wound exudate while maintaining optimal moisture levels, creating the ideal environment for cellular healing.

Antimicrobial Protection

Built-in silver ion technology provides continuous antimicrobial protection without cytotoxicity, reducing bioburden and infection risk.

Why Focus on These Products?

65% of wounds encompass three main conditions – Diabetic, Pressure, and Venous Ulcers.

The estimated annual cost burden for care of diabetic foot disease is $18.7 billion for Medicare recipients, and approximately $80 billion for overall treatment across all age groups.

Amnion-Chorion Membranes

Measurable Clinical Outcomes

VenoHeal™ has demonstrated exceptional results in clinical settings, significantly outperforming traditional venous ulcer treatments across all key metrics.

Superior Healing Rates

In comparative studies, VenoHeal™ has consistently demonstrated accelerated healing rates and improved patient outcomes compared to standard compression therapy alone.

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Faster healing times across all wound types compared to standard compression

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Reduction in wound-related complications when following VenoHeal™ protocols

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Success rate with challenging ulcers of >10cm² and >12 months duration

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Reduction in recurrence rates over 24-month follow-up period

Antimicrobial Protection

Antimicrobial peptides such as defensins and elafin in amniotic fluid confer intrinsic antibacterial properties, reducing infection rates in chronic wounds.

Dehydration and cryopreservation techniques preserve these biological attributes while extending shelf life, enabling off-the-shelf availability for clinical use.

Chronic Challenge

The Pathophysiology of DFUs

Advanced dHACM treatment protocol addressing the complex challenges of diabetic foot ulcers through a comprehensive approach that delivers consistently superior outcomes.

Diabetic foot ulcers develop through a complex interplay of pathophysiological factors that create a challenging wound healing environment. The diabetic wound microenvironment is characterized by persistent inflammation, impaired angiogenesis, and tissue hypoxia that significantly hinder normal healing processes. Elevated blood glucose levels lead to endothelial dysfunction, causing altered blood flow, increased vascular permeability, and changes in vascular growth factor expression. These vascular abnormalities contribute to impaired healing and chronic wounds.

Dehydrated human amnion/chorion membrane (dHACM) represents a revolutionary biological therapy for chronic DFUs. The placental membranes contain a rich extracellular matrix along with numerous growth factors and cytokines that contribute to their therapeutic potential. Our dHACM products include over 250 identified proteins that can influence various aspects of the wound healing process, actively regulating cell proliferation, migration, and differentiation while providing a scaffold that supports cell attachment.

Research Studies

Key Clinical Trials Overview

Comprehensive analysis of randomized controlled trials and comparative studies supporting the efficacy of amnion-chorion products

DEBTAL Trial

n=168 • 24-week

Objective: Compare acellular dermal matrices (ADMs) against standard care for DFUs
Methods: Multicenter RCT with 24-week follow-up period
Key Finding: Single applications of DermACELL® (amnion-chorion matrix) achieved 65% closure at 12 weeks versus 41.1% for standard care
p-Value: p<0.001
Walters et al. (2016), Int Wound J, 13(6):1111-1120

Snyder VLU Study

n=109 • 12-week

Objective: Evaluate dHACM as an adjunct to compression therapy for venous leg ulcers
Methods: 12-week randomized clinical trial with standard compression
Key Finding: dHACM plus compression therapy achieved 60% closure rate versus 35% for compression alone
Significance: Attributed to membrane's metalloproteinase inhibition and TGF-β3-mediated fibrotic regulation
Snyder et al. (2016), J Wound Care, 25(7):S22-S28

Zelen Comparative Study

n=100 • Multi-center

Objective: Compare dehydrated human amnion/chorion membrane (dHACM) with bilayered living cellular construct (BLCC)
Methods: Prospective, randomized, controlled multicenter clinical trial
Key Finding: 97% DFU closure with weekly dHACM versus 73% for BLCC, with median closure times of 23.6 versus 34 days
p-Value: p=0.0498
Zelen et al. (2014), Int Wound J, 13(6):1271-1277

Tettelbach DFU Study

n=110 • RCT

Objective: Evaluate efficacy of dHACM allograft for chronic DFUs
Methods: Prospective, randomized, controlled, multi-center clinical trial
Key Finding: dHACM showed 70% complete healing at 12 weeks vs. 50% for standard care alone
Hazard Ratio: 2.15 (95% CI 1.30-3.57)
Tettelbach et al. (2019), Int Wound J, 16(1):122-130

Meta-Analyses

Cost-Effectiveness Evidence

Comparative Cost Analysis

Methodology: 2019 cost-utility analysis (n=120 VLUs)

Result: SIS-amnion composite grafts reduced total treatment costs by 31% over 6 months due to fewer dressing changes and outpatient visits

ICER: $18,450 per QALY for dHACM in DFUs (below $50,000/QALY threshold)

Long-Term Economic Impact

Reduction in:

Hospital readmissions
Amputation rates
Nursing time
Overall treatment duration

Ongoing Clinical Trials

AMSC-Seeded Matrices (NCT04889213)

Status: Phase II, Recruiting

Focus: Evaluating AMSC-seeded chorion matrices for neuropathic DFUs

Preliminary Data: 89% closure at 16 weeks vs. 52% for acellular grafts

AI-Driven Customization (MultiTech-034)

Status: Pre-registration

Design: Adaptive platform trial using machine learning algorithms

Innovation: Matching dHACM variants to ulcer microenvironments based on proteomics

Expected Completion: Q4 2025

Strength of Evidence Assessment

Application	Evidence Level	Key Findings	Recommendation
Diabetic Foot Ulcers	Level I (High)	Multiple RCTs demonstrate superior healing rates (70-97%) and faster closure times	Strong recommendation for use in non-healing DFUs after 4 weeks of standard care
Venous Leg Ulcers	Level II (Moderate)	RCTs show 60% closure with adjunctive use; particularly effective for ulcers >12 weeks duration	Moderate recommendation as adjunct to compression therapy for refractory VLUs
Pressure Ulcers	Level II-III (Limited)	Small RCTs and cohort studies show promising results; larger studies needed	Conditional recommendation for Stage III-IV pressure ulcers after standard care failure
Surgical Wounds	Level III (Limited)	Case series show accelerated healing in complex surgical defects; limited comparative data	Consider for complex surgical wounds with exposed structures

Evidence Level Definitions:

Level I: Multiple high-quality RCTs with consistent findings

Level II: Single high-quality RCT or multiple lower-quality RCTs

Level III: Non-randomized controlled trials, cohort studies, or case series

Approximately 6.5 million people in the United States, or about 1 in 38 adults, are affected by chronic wounds each year.

* Chronic Wound Management: From Gauze to Homologous Cellular Matrix

DIABETIC FOOT ULCERS

Transformative Solutions for Diabetic Foot Ulcers

Significant cost savings

Medicare Approved

Diabetic Foot Wound Healing

Transforming DFU Care

Rapid Healing Technology

Simple Application System

Cost-Effective Care

Evidence-Based Protocol

Enhanced Patient Comfort

Advanced Cellular Technology

Advanced Treatment

VenoHeal™ Advanced Treatment System

Intelligent Pressure Distribution

Visual Application Indicators

Moisture Management Technology

Antimicrobial Protection

Why Focus on These Products?

Amnion-Chorion Membranes

Measurable Clinical Outcomes

Superior Healing Rates

Antimicrobial Protection

Chronic Challenge

The Pathophysiology of DFUs

Research Studies

Key Clinical Trials Overview

DEBTAL Trial

Snyder VLU Study

Zelen Comparative Study

Tettelbach DFU Study

Meta-Analyses

Cost-Effectiveness Evidence

Ongoing Clinical Trials

Strength of Evidence Assessment

Approximately 6.5 million people in the United States, or about 1 in 38 adults, are affected by chronic wounds each year.

1:38

adults have a chronic wound

Our Services

Contact

DIABETIC FOOT ULCERS

Transformative Solutions for Diabetic Foot Ulcers

Significant cost savings

Medicare Approved

Diabetic Foot Wound Healing

Transforming DFU Care

Advanced Treatment

VenoHeal™ Advanced Treatment System

Intelligent Pressure Distribution

Visual Application Indicators

Moisture Management Technology

Antimicrobial Protection

Why Focus on These Products?​

Amnion-Chorion Membranes

Measurable Clinical Outcomes

Superior Healing Rates

Antimicrobial Protection

Chronic Challenge

The Pathophysiology of DFUs

Research Studies

Key Clinical Trials Overview

Approximately 6.5 million people in the United States, or about 1 in 38 adults, are affected by chronic wounds each year.

1:38

adults have a chronic wound

Our Services

Contact

Why Focus on These Products?