Clinical trial NCT00958711: The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
Official title: The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetic Foot Ulcers
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Synovis Surgical Innovations
First posted: 2009-08-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Not Healed by Number of Days After Procedure
timeFrame: Day 20, Day 40, Day 60, Day 80
measure: Percentage of Participants With Wounds Healed at 12 Weeks
timeFrame: Week 12
measure: Wound Healing Pathway Markers
timeFrame: Day 0, 72 hours post-procedure, Week 1, Week 2, Week 4
measure: Bacterial Burden
timeFrame: Day 0, Week 1 - Week 12
Secondary outcomes:
measure: Percentage Mean of Original Wound Size From Baseline by Week
timeFrame: Day 0, Week 4, Week 8, Week 12
measure: Number of Participants With Ulcer Recurrence
timeFrame: Week 1 to Week 24
measure: Number of Device-related Adverse Events (AE)
timeFrame: Week 1 to Week 24
measure: Number of Procedure-related Adverse Events (AE)
timeFrame: Week 1 to Week 24
measure: Number of Device Failures
timeFrame: Week 1 to Week 24
measure: Number of Device Removals
timeFrame: Week 1 to Week 24
measure: Ease of Dressing Use
timeFrame: Week 1 to Week 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California - San Diego
state: California
city: Miami
country: United States
facility: University of Miami, Miller School of Medicine
state: Florida
city: Evans
country: United States
facility: Aiyan Diabetes Center
state: Georgia
city: Springfield
country: United States
facility: Foot & Ankle Associates of Central Illinois, LLC
state: Illinois
city: Greenville
country: United States
facility: Eastern Carolina Foot and Ankle
state: North Carolina
city: Greenville
country: United States
facility: Foot and Ankle East
state: North Carolina
city: Greenville
country: United States
facility: Carolina East Family Medicine
state: North Carolina
city: Greenville
country: United States
facility: Family Foot & Ankle Physicians
state: North Carolina
city: Kinston
country: United States
facility: Comprehensive Wound Care Thoracic & Vascular Associates of Kinston P.A.
state: North Carolina
city: Rocky Mount
country: United States
facility: The Foot & Ankle Associates of North Carolina, PLLC
state: North Carolina
city: York
country: United States
facility: Martin Foot and Ankle
state: Pennsylvania
Study officials:
References: