Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
2 participants
INTERVENTIONAL
2013-02-28
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sterilised, Porcine Placental Tissue in the Treatment of Chronic Diabetic Foot Ulcers
NCT05687656
Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers
NCT07089602
Biofilm Modified Macrophage Phenotype and Function in Diabetic Wound Healing
NCT03271580
Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study
NCT02309684
Clinical and Mechanistic Demonstration of a Bioelectric Dressing System for Non-healing Wound Management: A Phase II Trial
NCT01784887
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ECM in Saline
ECM
ECM in saline applied to wound
Blood Products
Blood Products
Autologous blood product applied to wound, with saline cleanse on alternating weeks
ECM in Blood Products
ECM in Blood Products
Alternating treatments of ECM in saline and ECM in autologous blood products, applied to wound
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ECM
ECM in saline applied to wound
Blood Products
Autologous blood product applied to wound, with saline cleanse on alternating weeks
ECM in Blood Products
Alternating treatments of ECM in saline and ECM in autologous blood products, applied to wound
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ulcer has been present between 12 and 52 weeks
* Ulcer is less than 40 cm2 in area
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cook Group Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John Embil, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Health Sciences Centre
Winnipeg, Manitoba, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
12-014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.