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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01228526
First Posted: October 26, 2010
Last Update Posted: August 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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
  Purpose
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 ]

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)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diabetic foot ulcer and meet the inclusion/exclusion criteria
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01228526


Locations
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
Investigators
Principal Investigator: Steven Kavros, DPM Mayo Clinic
  More Information

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT01228526     History of Changes
Other Study ID Numbers: TEI-003
First Submitted: October 25, 2010
First Posted: October 26, 2010
Last Update Posted: August 26, 2016
Last Verified: August 2016

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