ECM and Blood Components for Wound Healing

Cook Group

Status: Terminated

Conditions: Foot Ulcer, Diabetic; Ulcer; Venous Ulcer

Treatments: Device: ECM; Device: ECM in Blood Products; Biological: Blood Products

Study type: Interventional

Funder types: Industry

Identifiers

NCT01909908

12-014

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2 participants in 3 patient groups

ECM in Saline

Experimental group

Treatment:

Device: ECM

Blood Products

Active Comparator group

Treatment:

Biological: Blood Products

ECM in Blood Products

Experimental group

Treatment:

Device: ECM in Blood Products