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

This study has been completed.
Sponsor:
Collaborators:
Mayo Clinic
California School of Podiatric Medicine
New York College of Podiatric Medicine
Temple University
Circleville Foot & Ankle
Information provided by (Responsible Party):
TEI Biosciences Inc.
ClinicalTrials.gov Identifier:
NCT01228526
First received: October 25, 2010
Last updated: November 7, 2012
Last verified: November 2012
  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 TEI Biosciences Inc.:

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

Ages Eligible for Study:   18 Years and older
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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228526

Locations
United States, California
California School of Podiatric Medicine
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
United States, Pennsylvania
Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
TEI Biosciences Inc.
Mayo Clinic
California School of Podiatric Medicine
New York College of Podiatric Medicine
Temple University
Circleville Foot & Ankle
Investigators
Principal Investigator: Steven Kavros, DPM Mayo Clinic
  More Information

No publications provided

Responsible Party: TEI Biosciences Inc.
ClinicalTrials.gov Identifier: NCT01228526     History of Changes
Other Study ID Numbers: TEI-003
Study First Received: October 25, 2010
Last Updated: November 7, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on April 16, 2014