Study Stopped
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The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
1 other identifier
interventional
90
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2009
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 11, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
December 18, 2019
CompletedDecember 18, 2019
December 1, 2019
3.3 years
August 11, 2009
September 3, 2019
December 3, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of Participants Not Healed by Number of Days After Procedure
Time to complete healing was captured by Kaplan-Meier Plot showing percentage of participants not healed by number of days after procedure. Patients were considered healed at their first follow-up visit where the patient's would had healed.
Day 20, Day 40, Day 60, Day 80
Percentage of Participants With Wounds Healed at 12 Weeks
Week 12
Wound Healing Pathway Markers
Day 0, 72 hours post-procedure, Week 1, Week 2, Week 4
Bacterial Burden
Day 0, Week 1 - Week 12
Secondary Outcomes (7)
Percentage Mean of Original Wound Size From Baseline by Week
Day 0, Week 4, Week 8, Week 12
Number of Participants With Ulcer Recurrence
Week 1 to Week 24
Number of Device-related Adverse Events (AE)
Week 1 to Week 24
Number of Procedure-related Adverse Events (AE)
Week 1 to Week 24
Number of Device Failures
Week 1 to Week 24
- +2 more secondary outcomes
Study Arms (2)
Biologic - Unite Biomatrix
EXPERIMENTALSaline and Gauze
ACTIVE COMPARATORInterventions
Collagen based, decellularized equine pericardial dressing for skin surface wounds
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baxter Healthcare Corporationlead
- Synovis Surgical Innovationscollaborator
Study Sites (11)
University of California - San Diego
San Diego, California, 92103, United States
University of Miami, Miller School of Medicine
Miami, Florida, 33136, United States
Aiyan Diabetes Center
Evans, Georgia, 30809, United States
Foot & Ankle Associates of Central Illinois, LLC
Springfield, Illinois, 62704, United States
Eastern Carolina Foot and Ankle
Greenville, North Carolina, 27834, United States
Foot and Ankle East
Greenville, North Carolina, 27834, United States
Carolina East Family Medicine
Greenville, North Carolina, 27858, United States
Family Foot & Ankle Physicians
Greenville, North Carolina, 27858, United States
Comprehensive Wound Care Thoracic & Vascular Associates of Kinston P.A.
Kinston, North Carolina, 28504, United States
The Foot & Ankle Associates of North Carolina, PLLC
Rocky Mount, North Carolina, 27804, United States
Martin Foot and Ankle
York, Pennsylvania, 17403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study initially sponsored by Synovis Surgical Innovation, and product now licensed with Biomed Design. Unable to obtain all data for study. Clinical Study Report not located and results summarized from an abbreviated Statistical Analysis Report.
Results Point of Contact
- Title
- Baxter Clinical Trials Disclosure Call Center
- Organization
- Baxter Healthcare
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2009
First Posted
August 13, 2009
Study Start
January 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
December 18, 2019
Results First Posted
December 18, 2019
Record last verified: 2019-12