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

Sponsor

Integra LifeSciences Corporation (Industry)

Overall Status

Terminated

CT.gov ID

NCT01612806

Collaborator

(none)

Enrollment

Locations

Arms

68.1

Duration (Months)

6.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Venous Stasis Ulcer	Device: PriMatrix Device: PriMatrix Ag Procedure: moist wound therapy	N/A

Detailed Description

Healing percentages

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

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	Device: PriMatrix Ag fetal bovine dermal scaffold with Ag Procedure: moist wound therapy standard of care moist wound therapy
Active Comparator: Standard of Care Standard of Care Moist Wound Therapy	Procedure: moist wound therapy standard of care moist wound therapy

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

Device: PriMatrix Ag

fetal bovine dermal scaffold with Ag

Procedure: moist wound therapy

standard of care moist wound therapy

Active Comparator: Standard of Care

Standard of Care Moist Wound Therapy

Procedure: moist wound therapy

standard of care moist wound therapy

Outcome Measures

Primary Outcome Measures

Percent of VLUs healed by week 12 post-randomization [12 weeks]

Secondary Outcome Measures

Cost of treatment [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Caribbean Clinical Trials	Hato Rey	Puerto Rico	00918
2	Dr. Pila Metropolitan Hospital Wound Healing Center	Ponce	Puerto Rico	00717
3	Doctors' Center Hospital of San Juan	San Juan	Puerto Rico	00918
4	Wound and Ulcer Care Clinic of San Juan	San Juan	Puerto Rico	00918
5	Wilma N. Vazquez Hospital	Vega Baja	Puerto Rico	00694

Sponsors and Collaborators

Integra LifeSciences Corporation

Investigators

Study Director: John Starinski, DPM, TEI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Integra LifeSciences Corporation

ClinicalTrials.gov Identifier:

NCT01612806

Other Study ID Numbers:

TEI-006

First Posted:

Jun 6, 2012

Last Update Posted:

Aug 8, 2017

Last Verified:

Aug 1, 2017

Additional relevant MeSH terms:

Varicose Ulcer

Leg Ulcer

Ulcer

Study Results

No Results Posted as of Aug 8, 2017