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

March 29, 2024 updated by: Integra LifeSciences Corporation

A Multi-center, Prospective, Randomized Study With PriMatrix Dermal Repair Scaffold, PriMatrix Ag Antimicrobial Dermal Repair Scaffold, and Standard of Care for the Treatment of Venous Leg Ulcers

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Healing percentages

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Dr. Pila Metropolitan Hospital Wound Healing Center
      • San Juan, Puerto Rico, 00918
        • Doctors' Center Hospital of San Juan
      • San Juan, Puerto Rico, 00918
        • Wound and Ulcer Care Clinic of San Juan
      • San Juan, Puerto Rico, 00918
        • Caribbean Clinical Trials
      • Vega Baja, Puerto Rico, 00694
        • Wilma N. Vazquez Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PriMatrix
PriMatrix Dermal Repair Scaffold
Device: PriMatrix
fetal bovine dermal scaffold
Procedure: moist wound therapy
standard of care moist wound therapy
Experimental: PriMatrix Ag
PriMatrix Ag Antimicrobial Dermal Repair Scaffold
Procedure: moist wound therapy
standard of care moist wound therapy
Device: PriMatrix Ag
fetal bovine dermal scaffold with Ag
Active Comparator: Standard of Care
Standard of Care Moist Wound Therapy
Procedure: moist wound therapy
standard of care moist wound therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of VLUs healed by week 12 post-randomization
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost of treatment
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integra LifeSciences Corporation

Investigators

  • Study Director: John Starinski, DPM, TEI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 5, 2012

First Posted (Estimated)

June 6, 2012

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEI-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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