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

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ClinicalTrials.gov Identifier: NCT01270633
Recruitment Status : Terminated (Business Decision)
First Posted : January 5, 2011
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Foot Ulcer, Diabetic Device: PriMatrix Other: Standard of Care Not Applicable

Detailed Description:
Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2010
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Treatment
PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy.
Device: PriMatrix
Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy
Active Comparator: Standard of Care
Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained.
Other: Standard of Care
Following sharp debridement, moist wound therapy



Primary Outcome Measures :
  1. Percent of study ulcers healed [ Time Frame: 12 weeks post-randomization ]
    Percent of study ulcers healed at week 12 post-randomization


Secondary Outcome Measures :
  1. Cost of Treatment [ Time Frame: 12 weeks ]


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
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

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): NCT01270633


Locations
United States, Georgia
HyperbaRXs
Cumming, Georgia, United States, 30041
United States, Michigan
Covenant Medical Center
Saginaw, Michigan, United States, 48602
Puerto Rico
Professional Hospital
Guaynabo, Puerto Rico, 00717
Dr. Pila Metropolitan Hospital Wound Healing Center
Ponce, Puerto Rico, 00717
Caribbean Clinical Trials
San Juan, Puerto Rico, 00918
Doctors' Center Hospital of San Juan
San Juan, Puerto Rico, 00918
Wound and Ulcer Care Clinic of San Juan
San Juan, Puerto Rico, 00918
Wilma N. Vazquez Hospital
Vega Baja, Puerto Rico, 00694
Sponsors and Collaborators
Integra LifeSciences Corporation
Investigators
Study Chair: Yiannis Monovoukas, PhD TEI

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT01270633     History of Changes
Other Study ID Numbers: TEI-004
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

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