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

Integra LifeSciences

Status: Completed

Conditions: Foot Ulcers, Diabetic

Treatments: Device: PriMatrix

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01228526

TEI-003

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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