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

Not Applicable

Terminated

• Conditions: Venous Stasis Ulcer
• Interventions: Device: PriMatrix; Device: PriMatrix Ag; Procedure: moist wound therapy

• Registration Number: NCT01612806
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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

Detailed Description

Healing percentages

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-06
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PriMatrix	PriMatrix	PriMatrix Dermal Repair Scaffold
PriMatrix Ag	moist wound therapy	PriMatrix Ag Antimicrobial Dermal Repair Scaffold
PriMatrix Ag	PriMatrix Ag	PriMatrix Ag Antimicrobial Dermal Repair Scaffold
PriMatrix	moist wound therapy	PriMatrix Dermal Repair Scaffold
Standard of Care	moist wound therapy	Standard of Care Moist Wound Therapy

Primary Outcome Measures

Name	Time	Method
Percent of VLUs healed by week 12 post-randomization	12 weeks

Secondary Outcome Measures

Name	Time	Method
Cost of treatment	12 weeks

Trial Locations

Locations (5)

Caribbean Clinical Trials; 🇵🇷 San Juan, Puerto Rico

Dr. Pila Metropolitan Hospital Wound Healing Center; 🇵🇷 Ponce, Puerto Rico

Doctors' Center Hospital of San Juan; 🇵🇷 San Juan, Puerto Rico

Wound and Ulcer Care Clinic of San Juan; 🇵🇷 San Juan, Puerto Rico

Wilma N. Vazquez Hospital; 🇵🇷 Vega Baja, Puerto Rico