A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers

Integra LifeSciences

Status: Terminated

Conditions: Venous Stasis Ulcer

Treatments: Device: PriMatrix; Device: PriMatrix Ag; Procedure: moist wound therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01612806

TEI-006

Details and patient eligibility

About

To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).

Full description

Healing percentages

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women ≥ 18 years of age
• Ankle-brachial index (ABI) > 0.80
• Study wound 2-64 cm2 surface area
• Wound does not exhibit a greater than 50% reduction in surface area during the screening period

Exclusion criteria

• Suspected or confirmed signs/symptoms of wound infection
• Hypersensitivity to bovine collagen
• Body Mass Index (BMI) ≥ 45

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 3 patient groups

PriMatrix

Experimental group

Description:

PriMatrix Dermal Repair Scaffold

Treatment:

Procedure: moist wound therapy

Device: PriMatrix

PriMatrix Ag

Experimental group

Description:

PriMatrix Ag Antimicrobial Dermal Repair Scaffold

Treatment:

Device: PriMatrix Ag

Procedure: moist wound therapy

Standard of Care

Active Comparator group

Description:

Standard of Care Moist Wound Therapy

Treatment:

Procedure: moist wound therapy