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

This study has been terminated.
(Business Decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01270633
First Posted: January 5, 2011
Last Update Posted: December 1, 2017
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.
Information provided by (Responsible Party):
Integra LifeSciences Corporation
January 4, 2011
January 5, 2011
December 1, 2017
December 2010
September 2017   (Final data collection date for primary outcome measure)
Percent of study ulcers healed [ Time Frame: 12 weeks post-randomization ]
Percent of study ulcers healed at week 12 post-randomization
Same as current
Complete list of historical versions of study NCT01270633 on ClinicalTrials.gov Archive Site
Cost of Treatment [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Foot Ulcer, Diabetic
  • Device: PriMatrix
    Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy
  • Other: Standard of Care
    Following sharp debridement, moist wound therapy
  • Treatment
    PriMatrix applied to appropriately debrided wound bed and covered with a non-adherent dressing. Dressings applied to maintain moist wound therapy.
    Intervention: Device: PriMatrix
  • Active Comparator: Standard of Care
    Non adherent dressing applied to appropriately debrided wound bed and moist wound therapy maintained.
    Intervention: Other: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
September 2017
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT01270633
TEI-004
No
Not Provided
Not Provided
Integra LifeSciences Corporation
Integra LifeSciences Corporation
Not Provided
Study Chair: Yiannis Monovoukas, PhD TEI
Integra LifeSciences Corporation
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP