The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer

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. Identifier: NCT00958711
Recruitment Status : Terminated (Budgetary)
First Posted : August 13, 2009
Last Update Posted : May 17, 2012
Information provided by (Responsible Party):
Synovis Surgical Innovations

Brief Summary:
The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, saline moistened gauze, for the treatment of diabetic foot ulcers.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Device: Unite Biomatrix Other: Saline and Gauze Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
Study Start Date : January 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Biologic - Unite Biomatrix Device: Unite Biomatrix
Collagen based, decellularized equine pericardial dressing for skin surface wounds
Active Comparator: Saline and Gauze Other: Saline and Gauze
gauze moistened with sterile saline

Primary Outcome Measures :
  1. time to complete healing [ Time Frame: Day -7 (baseline), day 0, 72 hours, wk 1, wk 2, wk 4 ]
  2. percent of wounds healed at 12 weeks [ Time Frame: Day 0, wks 1 - 12 ]
  3. wound healing pathway markers [ Time Frame: day 0, 72 hours, wk 1, wk 2, wk 4 ]
  4. bacterial burden [ Time Frame: day 0, wk 1 - 12 ]

Secondary Outcome Measures :
  1. 1) mean & median of % wound size changes 2) ulcer recurrence 3) adverse events [ Time Frame: wk 4, wk 8, wk 12 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale).
  2. Diagnosis of diabetes mellitus (type I or II) adequately controlled.
  3. The ulcer is greater than 4 weeks duration.
  4. Three or fewer ulcers separated by > 3.0 cm distance.
  5. Post-debridement, the ulcer size must be between 1 and 10 sq cm2.
  6. Ankle/brachial index is between 0.7 to 1.2 and or one of the following must be present:

    • transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle
    • toe pressure of >40mm Hg or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
  7. At least 18 years old.
  8. Able and willing to provide a voluntary written informed consent.
  9. Able and willing to wear an off-loading orthopedic shoe.
  10. Able and willing to attend scheduled follow-up visits and study related exams.

Exclusion Criteria:

  1. Greater than 30% reduction in wound size during first week of observation by the investigator.
  2. Ulcer with exposed tendon or bone.
  3. Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis.
  4. Gangrene.
  5. Active Charcot's disease as determined by clinical and radiographic examination.
  6. Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers).
  7. Known severe anemia.
  8. Known serum albumin < 2.5.
  9. Renal failure with Creatinine > 2.5.
  10. Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV.
  11. Severe liver disease as defined by the treating physician or patient's primary care physician.
  12. Malignancy at or near the ulcer site.
  13. Any condition judged by the investigator that would cause the study to be detrimental to the patient.
  14. Presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator.
  15. Received another investigational device or drug within 30 days of Day 0.
  16. Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment.
  17. Received another allograft, autograft or xenograft within 30 days of the Day 0.
  18. Known allergy to equine derived tissue.
  19. Alcohol or drug abuse, defined as current medical treatment for substance abuse.
  20. Pregnant or nursing women.

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 identifier (NCT number): NCT00958711

United States, California
University of California - San Diego
San Diego, California, United States, 92103
United States, Florida
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Aiyan Diabetes Center
Evans, Georgia, United States, 30809
United States, Illinois
Foot & Ankle Associates of Central Illinois, LLC
Springfield, Illinois, United States, 62704
United States, North Carolina
Eastern Carolina Foot and Ankle
Greenville, North Carolina, United States, 27834
Foot and Ankle East
Greenville, North Carolina, United States, 27834
Carolina East Family Medicine
Greenville, North Carolina, United States, 27858
Family Foot & Ankle Physicians
Greenville, North Carolina, United States, 27858
Comprehensive Wound Care Thoracic & Vascular Associates of Kinston P.A.
Kinston, North Carolina, United States, 28504
The Foot & Ankle Associates of North Carolina, PLLC
Rocky Mount, North Carolina, United States, 27804
United States, Pennsylvania
Martin Foot and Ankle
York, Pennsylvania, United States, 17403
Sponsors and Collaborators
Synovis Surgical Innovations

Responsible Party: Synovis Surgical Innovations Identifier: NCT00958711     History of Changes
Other Study ID Numbers: U-0801
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: September 2011

Additional relevant MeSH terms:
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