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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Device: Unite Biomatrix; Other: Saline and Gauze

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • University of California - San Diego
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami, Miller School of Medicine
  • Georgia
    • Evans, Georgia, United States, 30809
      • Aiyan Diabetes Center
  • Illinois
    • Springfield, Illinois, United States, 62704
      • Foot & Ankle Associates of Central Illinois, LLC
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • Carolina East Family Medicine
    • Greenville, North Carolina, United States, 27834
      • Eastern Carolina Foot and Ankle
    • Greenville, North Carolina, United States, 27834
      • Foot and Ankle East
    • Greenville, North Carolina, United States, 27858
      • Family Foot & Ankle Physicians
    • Kinston, North Carolina, United States, 28504
      • Comprehensive Wound Care Thoracic & Vascular Associates of Kinston P.A.
    • Rocky Mount, North Carolina, United States, 27804
      • The Foot & Ankle Associates of North Carolina, PLLC
  • Pennsylvania
    • York, Pennsylvania, United States, 17403
      • Martin Foot and Ankle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Synovis Surgical Innovations

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: August 11, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimate): August 13, 2009

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: U-0801