ECM and Blood Components for Wound Healing

Not Applicable

Terminated

• Conditions: Foot Ulcer, Diabetic; Venous Ulcer; Ulcer
• Interventions: Biological: Blood Products; Device: ECM in Blood Products; Device: ECM

• Registration Number: NCT01909908
• Lead Sponsor: Cook Group Incorporated

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 available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-29
• Primary Completion: 2016-06
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood Products	Blood Products	-
ECM in Blood Products	ECM in Blood Products	-
ECM in Saline	ECM	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	12 weeks

Trial Locations

Locations (1)

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada