Status:
TERMINATED
The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
Lead Sponsor:
Baxter Healthcare Corporation
Collaborating Sponsors:
Synovis Surgical Innovations
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale).
- Diagnosis of diabetes mellitus (type I or II) adequately controlled.
- The ulcer is greater than 4 weeks duration.
- Three or fewer ulcers separated by \> 3.0 cm distance.
- Post-debridement, the ulcer size must be between 1 and 10 sq cm2.
- 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)
- At least 18 years old.
- Able and willing to provide a voluntary written informed consent.
- Able and willing to wear an off-loading orthopedic shoe.
- Able and willing to attend scheduled follow-up visits and study related exams.
Exclusion
- Greater than 30% reduction in wound size during first week of observation by the investigator.
- Ulcer with exposed tendon or bone.
- Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis.
- Gangrene.
- Active Charcot's disease as determined by clinical and radiographic examination.
- Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers).
- Known severe anemia.
- Known serum albumin \< 2.5.
- Renal failure with Creatinine \> 2.5.
- Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV.
- Severe liver disease as defined by the treating physician or patient's primary care physician.
- Malignancy at or near the ulcer site.
- Any condition judged by the investigator that would cause the study to be detrimental to the patient.
- 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.
- Received another investigational device or drug within 30 days of Day 0.
- Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment.
- Received another allograft, autograft or xenograft within 30 days of the Day 0.
- Known allergy to equine derived tissue.
- Alcohol or drug abuse, defined as current medical treatment for substance abuse.
- Pregnant or nursing women.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00958711
Start Date
January 1 2009
End Date
May 1 2012
Last Update
December 18 2019
Active Locations (11)
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1
University of California - San Diego
San Diego, California, United States, 92103
2
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
3
Aiyan Diabetes Center
Evans, Georgia, United States, 30809
4
Foot & Ankle Associates of Central Illinois, LLC
Springfield, Illinois, United States, 62704