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

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ClinicalTrials.gov Identifier: NCT01228526
Recruitment Status : Completed
First Posted : October 26, 2010
Last Update Posted : August 26, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.

Condition or disease Intervention/treatment
Foot Ulcers, Diabetic Device: PriMatrix

Study Design

Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : August 2010
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Percent of study ulcers healed [ Time Frame: Week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: October 26, 2010    Key Record Dates
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