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A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers
1 other identifier
interventional
31
1 country
5
Brief Summary
To evaluate the effectiveness of PriMatrix, PriMatrix Ag, and Standard of Care in the treatment of venous leg ulcers (VLUs).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedApril 1, 2024
March 1, 2024
5.7 years
June 4, 2012
March 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of VLUs healed by week 12 post-randomization
12 weeks
Secondary Outcomes (1)
Cost of treatment
12 weeks
Study Arms (3)
PriMatrix
EXPERIMENTALPriMatrix Dermal Repair Scaffold
PriMatrix Ag
EXPERIMENTALPriMatrix Ag Antimicrobial Dermal Repair Scaffold
Standard of Care
ACTIVE COMPARATORStandard of Care Moist Wound Therapy
Interventions
standard of care moist wound therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Suspected or confirmed signs/symptoms of wound infection
- Hypersensitivity to bovine collagen
- Body Mass Index (BMI) ≥ 45
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Caribbean Clinical Trials
San Juan, PR, 00918, Puerto Rico
Dr. Pila Metropolitan Hospital Wound Healing Center
Ponce, 00717, Puerto Rico
Doctors' Center Hospital of San Juan
San Juan, 00918, Puerto Rico
Wound and Ulcer Care Clinic of San Juan
San Juan, 00918, Puerto Rico
Wilma N. Vazquez Hospital
Vega Baja, 00694, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Starinski, DPM
TEI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 6, 2012
Study Start
June 1, 2011
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
April 1, 2024
Record last verified: 2024-03