A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers

Integra LifeSciences Corporation22 enrolled

Overview

To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Foot Ulcers, Diabetic

Interventions

PriMatrixDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type I or Type II diabetes with investigator-confirmed reasonable metabolic control * Peripheral neuropathy * A full thickness diabetic plantar foot ulcer of at least 1 cm2 but not exceeding 10 cm2 in area * An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening Exclusion Criteria: * Suspected or confirmed signs/symptoms of wound infection * Wounds with exposed bone or tendon * Hypersensitivity to bovine collagen

Locations (5)

California School of Podiatric Medicine at Samuel Merritt University

Oakland, California, United States

Mayo Clinic

Rochester, Minnesota, United States

New York College of Podiatric Medicine

New York, New York, United States

Circleville Foot & Ankle

Circleville, Ohio, United States

Outcomes

Primary Outcomes

Percent of study ulcers healed

Time frame: Week 12

Data from ClinicalTrials.gov

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