Status:
TERMINATED
ECM and Blood Components for Wound Healing
Lead Sponsor:
Cook Group Incorporated
Conditions:
Ulcer
Venous Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01909908
Start Date
February 1 2013
End Date
September 1 2016
Last Update
September 29 2016
Active Locations (1)
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1
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9