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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 13, 2014
Last verified: November 2014
History of Changes

January 4, 2011
November 13, 2014
December 2010
September 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01270633 on ClinicalTrials.gov Archive Site
Cost of Treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Completed
30
September 2012
September 2012   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01270633
TEI-004
No
TEI Biosciences Inc.
TEI Biosciences Inc.
Not Provided
Study Chair: Yiannis Monovoukas, PhD TEI
TEI Biosciences Inc.
November 2014

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