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

Venous Stasis Ulcer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01612806
• Other study ID #: TEI-006
• Status: Terminated
• Phase: N/A
• Start date: June 2011
• Est. completion date: February 2017

Study information

• Verified date: March 2024
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Healing percentages

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Stasis Ulcer

Intervention

Device:
• PriMatrix
fetal bovine dermal scaffold
• PriMatrix Ag
fetal bovine dermal scaffold with Ag

Procedure:
• moist wound therapy
standard of care moist wound therapy

Locations

Country	Name	City	State
Puerto Rico	Dr. Pila Metropolitan Hospital Wound Healing Center	Ponce
Puerto Rico	Caribbean Clinical Trials	San Juan
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

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of VLUs healed by week 12 post-randomization		12 weeks
Secondary	Cost of treatment		12 weeks