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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01612806

Enrollment

Registered

2012-06-06

Start date

2011-06-30

Completion date

2017-02-28

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Stasis Ulcer

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

Interventions

DEVICEPriMatrix

fetal bovine dermal scaffold

DEVICEPriMatrix Ag

fetal bovine dermal scaffold with Ag

PROCEDUREmoist wound therapy

standard of care moist wound therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Percent of VLUs healed by week 12 post-randomization	12 weeks

Secondary

Measure	Time frame
Cost of treatment	12 weeks

Countries

Puerto Rico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026