The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
NCT ID: NCT00958711
Last Updated: 2019-12-18
Study Results
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View full resultsBasic Information
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TERMINATED
NA
90 participants
INTERVENTIONAL
2009-01-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Biologic - Unite Biomatrix
Unite Biomatrix
Collagen based, decellularized equine pericardial dressing for skin surface wounds
Saline and Gauze
Saline and Gauze
gauze moistened with sterile saline
Interventions
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Unite Biomatrix
Collagen based, decellularized equine pericardial dressing for skin surface wounds
Saline and Gauze
gauze moistened with sterile saline
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Synovis Surgical Innovations
INDUSTRY
Baxter Healthcare Corporation
INDUSTRY
Responsible Party
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Locations
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University of California - San Diego
San Diego, California, United States
University of Miami, Miller School of Medicine
Miami, Florida, United States
Aiyan Diabetes Center
Evans, Georgia, United States
Foot & Ankle Associates of Central Illinois, LLC
Springfield, Illinois, United States
Eastern Carolina Foot and Ankle
Greenville, North Carolina, United States
Foot and Ankle East
Greenville, North Carolina, United States
Carolina East Family Medicine
Greenville, North Carolina, United States
Family Foot & Ankle Physicians
Greenville, North Carolina, United States
Comprehensive Wound Care Thoracic & Vascular Associates of Kinston P.A.
Kinston, North Carolina, United States
The Foot & Ankle Associates of North Carolina, PLLC
Rocky Mount, North Carolina, United States
Martin Foot and Ankle
York, Pennsylvania, United States
Countries
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Other Identifiers
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U-0801
Identifier Type: -
Identifier Source: org_study_id