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OpenTrials
Completed

NCT Number: NCT01228526

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.

Completed

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Key information

Conditions

Foot Ulcers, Diabetic Foot Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

California School of Podiatric Medicine at Samuel Merritt University, Oakland, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PriMatrix

Device

Primary outcomes

  1. Percent of study ulcers healed

    Time frame: Week 12

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Circleville Foot & Ankle LLC
  • Mayo Clinic
  • New York College of Podiatric Medicine
  • Samuel Merritt University
  • Temple University

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 26, 2010
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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