Back to resultsECM and Blood Components for Wound Healing
Primary Purpose
Ulcer, Venous Ulcer, Foot Ulcer, Diabetic
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ECM
Blood Products
ECM in Blood Products
Sponsored by
About this trial
This is an interventional treatment trial for Ulcer focused on measuring Wounds and injuries, Ulcer, Diabetic angiopathies, Diabetic foot, Venous insufficiency, Extracellular matrix
Eligibility Criteria
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
Sites / Locations
- Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
ECM in Saline
Blood Products
ECM in Blood Products
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT01909908
First Posted
July 25, 2013
Last Updated
September 28, 2016
Sponsor
Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01909908
Brief Title
ECM and Blood Components for Wound Healing
Official Title
Treatment of Chronic Wounds Using Extracellular Matrix-Based Devices and the Patient's Own Blood Components
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcer, Venous Ulcer, Foot Ulcer, Diabetic
Keywords
Wounds and injuries, Ulcer, Diabetic angiopathies, Diabetic foot, Venous insufficiency, Extracellular matrix
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECM in Saline
Arm Type
Experimental
Arm Title
Blood Products
Arm Type
Active Comparator
Arm Title
ECM in Blood Products
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ECM
Intervention Description
ECM in saline applied to wound
Intervention Type
Biological
Intervention Name(s)
Blood Products
Intervention Description
Autologous blood product applied to wound, with saline cleanse on alternating weeks
Intervention Type
Device
Intervention Name(s)
ECM in Blood Products
Intervention Description
Alternating treatments of ECM in saline and ECM in autologous blood products, applied to wound
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Embil, MD, FRCPC
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
12. IPD Sharing Statement
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ECM and Blood Components for Wound Healing
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