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

Not Applicable

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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.

Arm && Interventions

Group	Intervention	Description
Saline and Gauze	Saline and Gauze	-
Biologic - Unite Biomatrix	Unite Biomatrix	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Wounds Healed at 12 Weeks	Week 12
Bacterial Burden	Day 0, Week 1 - Week 12
Percentage of Participants Not Healed by Number of Days After Procedure	Day 20, Day 40, Day 60, Day 80	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.
Wound Healing Pathway Markers	Day 0, 72 hours post-procedure, Week 1, Week 2, Week 4

Secondary Outcome Measures

Name	Time	Method
Number of Device Removals	Week 1 to Week 24	Device removal is included in device failure under ITT. Subjects who experienced procedure-related events were also device failures under ITT. This endpoint is equivalent to device failure rates reported above.
Ease of Dressing Use	Week 1 to Week 12	Ease of usage on a 5-point scale where 1=greatest ease of use and 5=greatest difficult
Number of Participants With Ulcer Recurrence	Week 1 to Week 24
Number of Device Failures	Week 1 to Week 24	Includes failure to heal the ulcer by the 12-week visit under the Intent-to-Treat principle.
Number of Device-related Adverse Events (AE)	Week 1 to Week 24
Number of Procedure-related Adverse Events (AE)	Week 1 to Week 24
Percentage Mean of Original Wound Size From Baseline by Week	Day 0, Week 4, Week 8, Week 12	The percent of original wound size was calculated using the following formula: measure at baseline minus measure at follow-up visit divided by measure at baseline. In cases when the baseline depth was reported as 0cm, the minimum non-zero value in the sample (0.1cm) was imputed so a percent reduction measure could be calculated.

Locations (11): Aiyan Diabetes Center
🇺🇸
Evans, Georgia, United States
University of Miami, Miller School of Medicine
🇺🇸
Miami, Florida, United States
University of California - San Diego
🇺🇸
San Diego, California, 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
Martin Foot and Ankle
🇺🇸
York, Pennsylvania, United States
The Foot & Ankle Associates of North Carolina, PLLC
🇺🇸
Rocky Mount, North Carolina, United States