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

This study has been completed.
Mayo Clinic
Samuel Merritt University
New York College of Podiatric Medicine
Temple University
Circleville Foot & Ankle LLC
Information provided by (Responsible Party):
Integra LifeSciences Corporation Identifier:
First received: October 25, 2010
Last updated: August 25, 2016
Last verified: August 2016
To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.

Condition Intervention
Foot Ulcers, Diabetic
Device: PriMatrix

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Percent of study ulcers healed [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: August 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diabetic foot ulcer and meet the inclusion/exclusion criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01228526

United States, California
California School of Podiatric Medicine at Samuel Merritt University
Oakland, California, United States, 94609
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States
United States, New York
New York College of Podiatric Medicine
New York, New York, United States, 10035
United States, Ohio
Circleville Foot & Ankle
Circleville, Ohio, United States, 43113
United States, Pennsylvania
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Integra LifeSciences Corporation
Mayo Clinic
Samuel Merritt University
New York College of Podiatric Medicine
Temple University
Circleville Foot & Ankle LLC
Principal Investigator: Steven Kavros, DPM Mayo Clinic
  More Information

Responsible Party: Integra LifeSciences Corporation Identifier: NCT01228526     History of Changes
Other Study ID Numbers: TEI-003 
Study First Received: October 25, 2010
Last Updated: August 25, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Foot Ulcer
Diabetic Foot
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies processed this record on October 21, 2016