A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers
Overview
To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: September 2012
Interventions
- Device: PriMatrix
Clinical Trial Outcome Measures
Primary Measures
- Percent of study ulcers healed
- Time Frame: Week 12
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Integra LifeSciences Corporation
- Collaborator
- Mayo Clinic
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Steven Kavros, DPM, Principal Investigator, Mayo Clinic
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