Foot Ulcer, Diabetic, Ulcer, Venous Ulcer
Conditions
Keywords
Wounds and injuries, Ulcer, Diabetic angiopathies, Diabetic foot, Venous insufficiency, Extracellular matrix
Brief summary
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.
Interventions
DEVICEECM
ECM in saline applied to wound
BIOLOGICALBlood Products
Autologous blood product applied to wound, with saline cleanse on alternating weeks
DEVICEECM in Blood Products
Alternating treatments of ECM in saline and ECM in autologous blood products, applied to wound
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 12 weeks |
Countries
Canada
Outcome results
None listed