A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers
Completed
- Conditions
- Foot Ulcers, Diabetic
- Registration Number
- NCT01228526
- Lead Sponsor
- Integra LifeSciences Corporation
- Brief Summary
To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent of study ulcers healed Week 12
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Temple University School of Podiatric Medicine
🇺🇸Philadelphia, Pennsylvania, United States
New York College of Podiatric Medicine
🇺🇸New York, New York, United States
California School of Podiatric Medicine at Samuel Merritt University
🇺🇸Oakland, California, United States
Circleville Foot & Ankle
🇺🇸Circleville, Ohio, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States