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

Completed

Conditions studied: Foot Ulcers, Diabetic

In brief

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

Key facts

Study ID

NCT01228526

Run by

Integra LifeSciences Corporation

People needed

22

Starts

2010-08-01

Expected to finish

2012-09-01

Last updated by the study team

2016-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Suspected or confirmed signs/symptoms of wound infection
• Wounds with exposed bone or tendon
• Hypersensitivity to bovine collagen

Where it is running

• 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
• Temple University School of Podiatric Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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