Back to resultsA Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers
Primary Purpose
Venous Stasis Ulcer
Status
Terminated
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
PriMatrix
PriMatrix Ag
moist wound therapy
Sponsored by
About this trial
This is an interventional treatment trial for Venous Stasis Ulcer
Eligibility Criteria
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
Sites / Locations
- Caribbean Clinical Trials
- Dr. Pila Metropolitan Hospital Wound Healing Center
- Doctors' Center Hospital of San Juan
- Wound and Ulcer Care Clinic of San Juan
- Wilma N. Vazquez Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
PriMatrix
PriMatrix Ag
Standard of Care
Arm Description
PriMatrix Dermal Repair Scaffold
PriMatrix Ag Antimicrobial Dermal Repair Scaffold
Standard of Care Moist Wound Therapy
Outcomes
Primary Outcome Measures
Percent of VLUs healed by week 12 post-randomization
Secondary Outcome Measures
Cost of treatment
Full Information
NCT ID
NCT01612806
First Posted
June 4, 2012
Last Updated
August 7, 2017
Sponsor
Integra LifeSciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01612806
Brief Title
A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Site selection
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Stasis Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PriMatrix
Arm Type
Experimental
Arm Description
PriMatrix Dermal Repair Scaffold
Arm Title
PriMatrix Ag
Arm Type
Experimental
Arm Description
PriMatrix Ag Antimicrobial Dermal Repair Scaffold
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of Care Moist Wound Therapy
Intervention Type
Device
Intervention Name(s)
PriMatrix
Intervention Description
fetal bovine dermal scaffold
Intervention Type
Device
Intervention Name(s)
PriMatrix Ag
Intervention Description
fetal bovine dermal scaffold with Ag
Intervention Type
Procedure
Intervention Name(s)
moist wound therapy
Intervention Description
standard of care moist wound therapy
Primary Outcome Measure Information:
Title
Percent of VLUs healed by week 12 post-randomization
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cost of treatment
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Starinski, DPM
Organizational Affiliation
TEI
Official's Role
Study Director
Facility Information:
Facility Name
Caribbean Clinical Trials
City
Hato Rey
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Dr. Pila Metropolitan Hospital Wound Healing Center
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Doctors' Center Hospital of San Juan
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Wound and Ulcer Care Clinic of San Juan
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Wilma N. Vazquez Hospital
City
Vega Baja
ZIP/Postal Code
00694
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers
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