ECM and Blood Components for Wound Healing | NCT01909908

Studies
ECM and Blood Components for Wound Healing

NCT01909908

Sponsor

Cook Group Incorporated

Status

Terminated

Last Update Posted

Sep 29, 2016Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

Ulcer
Venous Ulcer
Foot Ulcer, Diabetic

Interventions

ECM
Blood Products
ECM in Blood Products

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow enrollment

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jun 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Jul 25, 2013

First Submission Date that Met QC Criteria

Jul 26, 2013

First Posted Date

Jul 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2016

Last Update Posted Date

Sep 29, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
ECM in Saline	Experimental	Device: ECM
Blood Products	Active Comparator	Biological: Blood Products
ECM in Blood Products	Experimental	Device: ECM in Blood Products

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECM	Device	ECM in saline applied to wound	ECM in Saline
Blood Products

Measure	Description	Time Frame
Incidence of adverse events		12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Embil, MD, FRCPC	University of Manitoba	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Sciences Centre		Winnipeg	Manitoba	R3A 1R9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D014456	Ulcer
D014647	Varicose Ulcer
D017719	Diabetic Foot
D014947	Wounds and Injuries
D003925	Diabetic Angiopathies
D014689	Venous Insufficiency

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014648	Varicose Veins
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided