Status:
COMPLETED
A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers
Lead Sponsor:
Integra LifeSciences Corporation
Collaborating Sponsors:
Mayo Clinic
Samuel Merritt University
Conditions:
Foot Ulcers, Diabetic
Eligibility:
All Genders
18+ years
Brief Summary
To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.
Eligibility Criteria
Inclusion
- 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
- Suspected or confirmed signs/symptoms of wound infection
- Wounds with exposed bone or tendon
- Hypersensitivity to bovine collagen
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01228526
Start Date
August 1 2010
End Date
September 1 2012
Last Update
August 26 2016
Active Locations (5)
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1
California School of Podiatric Medicine at Samuel Merritt University
Oakland, California, United States, 94609
2
Mayo Clinic
Rochester, Minnesota, United States
3
New York College of Podiatric Medicine
New York, New York, United States, 10035
4
Circleville Foot & Ankle
Circleville, Ohio, United States, 43113