NCT01909908TerminatedNot Applicable
Treatment of Chronic Wounds Using Extracellular Matrix-Based Devices and the Patient's Own Blood Components
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Cook Group Incorporated
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Blood Products
Active Comparator
Intervention: Blood Products (Biological)
ECM in Saline
Experimental
Intervention: ECM (Device)
ECM in Blood Products
Experimental
Intervention: ECM in Blood Products (Device)
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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