ECM and Blood Components for Wound Healing

Foot Ulcer, Diabetic Clinical Trial

Official title:

Treatment of Chronic Wounds Using Extracellular Matrix-Based Devices and the Patient's Own Blood Components

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01909908
• Other study ID #: 12-014
• Status: Terminated
• Phase: N/A
• First received: July 25, 2013
• Last updated: September 28, 2016
• Start date: February 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer
• Varicose Ulcer
• Venous Ulcer

Intervention

Device:
• ECM
ECM in saline applied to wound

Biological:
• Blood Products
Autologous blood product applied to wound, with saline cleanse on alternating weeks

Device:
• ECM in Blood Products
Alternating treatments of ECM in saline and ECM in autologous blood products, applied to wound

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		12 weeks	Yes