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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Device: Unite Biomatrix
* Other: Saline and Gauze


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biologic - Unite Biomatrix<br> | Device: Unite Biomatrix<br>* Collagen based, decellularized equine pericardial dressing for skin surface wounds<br>|
| Active Comparator: Saline and Gauze<br> | Other: Saline and Gauze<br>* gauze moistened with sterile saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Mean of Original Wound Size From Baseline by Week | 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. | 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 | Includes failure to heal the ulcer by the 12-week visit under the Intent-to-Treat principle. | Week 1 to Week 24 | 
| Number of Device Removals | 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. | Week 1 to Week 24 | 
| Ease of Dressing Use | Ease of usage on a 5-point scale where 1=greatest ease of use and 5=greatest difficult | Week 1 to Week 12 |