NCT01909908

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

3.3 years

First QC Date

July 25, 2013

Last Update Submit

September 28, 2016

Conditions

UlcerVenous UlcerFoot Ulcer, Diabetic

Keywords

Wounds and injuriesUlcerDiabetic angiopathiesDiabetic footVenous insufficiencyExtracellular matrix

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    12 weeks

Study Arms (3)

ECM in Saline

EXPERIMENTAL
Device: ECM

Blood Products

ACTIVE COMPARATOR
Biological: Blood Products

ECM in Blood Products

EXPERIMENTAL
Device: ECM in Blood Products

Interventions

ECMDEVICE

ECM in saline applied to wound

ECM in Saline
Blood ProductsBIOLOGICAL

Autologous blood product applied to wound, with saline cleanse on alternating weeks

Blood Products
ECM in Blood ProductsDEVICE

Alternating treatments of ECM in saline and ECM in autologous blood products, applied to wound

ECM in Blood Products

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

UlcerVaricose UlcerDiabetic FootWounds and InjuriesDiabetic AngiopathiesVenous Insufficiency

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVaricose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesFoot UlcerDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • John Embil, MD, FRCPC

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2013

First Posted

July 29, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

CA(1)