UlcerNCT01909908
ECM and Blood Components for Wound Healing
A study testing ECM, Blood Products and ECM in Blood Products in people with Ulcer and Venous Ulcer, run by Cook Group Incorporated at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer, Venous Ulcer, Foot Ulcer, Diabetic
- What is being tested?
- ECM, Blood Products and ECM in Blood Products
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Chronic Wounds Using Extracellular Matrix-Based Devices and the Patient's Own Blood Components
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.
- Conditions
- Ulcer, Venous Ulcer, Foot Ulcer, Diabetic
- Being tested
- ECM, Blood Products, ECM in Blood Products
- Keywords
- Wounds and injuries, Ulcer, Diabetic angiopathies, Diabetic foot, Venous insufficiency, Extracellular matrix
- Medical subject headings
- Ulcer, Varicose Ulcer, Diabetic Foot, Wounds and Injuries, Diabetic Angiopathies, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMDevice
ECM in saline applied to wound
Blood ProductsBiological
Autologous blood product applied to wound, with saline cleanse on alternating weeks
ECM in Blood ProductsDevice
Alternating treatments of ECM in saline and ECM in autologous blood products, applied to wound
| Study group | Role | What they receive |
|---|---|---|
| ECM in Saline | Experimental | Not described Receives: Device: ECM |
| Blood Products | Active comparator | Not described Receives: Biological: Blood Products |
| ECM in Blood Products | Experimental | Not described Receives: Device: ECM in Blood Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2016
- Study completionSep 2016
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Embil, MD, FRCPC, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909908
- Sponsor's protocol ID
- 12-014
- Status last verified
- Sep 2016
- First submitted
- 25 Jul 2013
- Last updated
- 29 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Wounds Using Extracellular Matrix-Based Devices and the Patient's Own Blood Components
- ClinicalTrials.gov ID
- NCT01909908
- Acronym / sponsor ID
- 12-014
- Conditions
- Ulcer, Venous Ulcer, Foot Ulcer, Diabetic
- Keywords
- Wounds and injuries, Ulcer, Diabetic angiopathies, Diabetic foot, Venous insufficiency, Extracellular matrix
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECM in Saline | Experimental | Device: ECM |
| Blood Products | Active comparator | Biological: Blood Products |
| ECM in Blood Products | Experimental | Device: ECM in Blood Products |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECMECM in saline applied to wound | Device | ECM in Saline |
| Blood ProductsAutologous blood product applied to wound, with saline cleanse on alternating weeks | Biological | Blood Products |
| ECM in Blood ProductsAlternating treatments of ECM in saline and ECM in autologous blood products, applied to wound | Device | ECM in Blood Products |
Primary outcome
Incidence of adverse events
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Embil, MD, FRCPC principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECM, Blood Products and ECM in Blood Products in people with Ulcer and Venous Ulcer, run by Cook Group Incorporated at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.