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A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TEI Biosciences Inc.
ClinicalTrials.gov Identifier:
NCT01270633
First received: January 4, 2011
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.


Condition Intervention
Foot Ulcer, Diabetic
 Device: PriMatrix
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by TEI Biosciences Inc.:

Primary Outcome Measures:
  • Percent of study ulcers healed [ Time Frame: 12 weeks post-randomization ] [ Designated as safety issue: No ]
    Percent of study ulcers healed at week 12 post-randomization


Secondary Outcome Measures:
  • Cost of Treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Device: PriMatrix
Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy
Active Comparator: Standard of Care Other: Standard of Care
Following sharp debridement, moist wound therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women ≥ 18 years of age and able to give their own consent
  • Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
  • Study ulcer has a Wagner grade of 1 or 2
  • Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement
  • A full thickness diabetic foot ulcer located on the foot or ankle
  • 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: NCT01270633

Locations
United States, Georgia
HyperbaRXs
Cumming, Georgia, United States
United States, Michigan
Covenant Medical Center
Saginaw, Michigan, United States
Puerto Rico
Professional Hospital
Guaynabo, Puerto Rico
Caribbean Clinical Trials
Hato Rey, Puerto Rico, 00918
Dr. Pila Metropolitan Hospital Wound Healing Center
Ponce, Puerto Rico
Wound and Ulcer Care Clinic of San Juan
San Juan, Puerto Rico
Doctors' Center Hospital of San Juan
San Juan, Puerto Rico
Wilma N. Vazquez Hospital
Vega Baja, Puerto Rico
Sponsors and Collaborators
TEI Biosciences Inc.
  More Information

No publications provided

Responsible Party: TEI Biosciences Inc.
ClinicalTrials.gov Identifier: NCT01270633     History of Changes
Other Study ID Numbers: TEI-004
Study First Received: January 4, 2011
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 May 23, 2013