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


To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2012


  • Device: PriMatrix

Clinical Trial Outcome Measures

Primary Measures

  • Percent of study ulcers healed
    • Time Frame: Week 12

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Integra LifeSciences Corporation
  • Collaborator
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Steven Kavros, DPM, Principal Investigator, Mayo Clinic

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