ECM and Blood Components for Wound Healing

Treatment of Chronic Wounds Using Extracellular Matrix-Based Devices and the Patient's Own Blood Components

The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM) and autologous blood products in wound healing.

Inclusion Criteria:

• Type 1 or Type 2 diabetes, and/or venous insufficiency to the affected leg
• Ulcer has been present between 12 and 52 weeks
• Ulcer is less than 40 cm2 in area

Exclusion Criteria:

• Less than 18 years of age
• Pregnant or planning to become pregnant during the study period
• Simultaneously participating in another investigational drug or device study
• Unable or unwilling to comply with the weekly study follow-up schedule or off-loading regimen
• Patient or legal representative refuses to sign the EC-approved informed consent form
• Known allergy to pig or porcine products
• Additional criteria may apply