ECM and Blood Components for Wound Healing

September 28, 2016 updated by: Cook Group Incorporated

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECM in Saline
Device: ECM
ECM in saline applied to wound
Active Comparator: Blood Products
Biological: Blood Products
Autologous blood product applied to wound, with saline cleanse on alternating weeks
Experimental: ECM in Blood Products
Device: ECM in Blood Products
Alternating treatments of ECM in saline and ECM in autologous blood products, applied to wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Investigators

  • Principal Investigator: John Embil, MD, FRCPC, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (Estimate)

July 29, 2013

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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