ECM and Blood Components for Wound Healing

N/ATerminatedNCT01909908

Cook Group Incorporated2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcer Venous Ulcer Foot Ulcer, Diabetic

Interventions

ECMDEVICE

ECM in saline applied to wound

Blood ProductsBIOLOGICAL

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

ECM in Blood ProductsDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Health Sciences Centre

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Incidence of adverse events

Time frame: 12 weeks

Data from ClinicalTrials.gov

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